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You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** # eness, # Participa and Safecy with a Novel Duar-Applicator Cryolipolysis System: A Prospective, Multicountry Study Geronemus, Roy G. MD^\*; Wang, Jordan V. MD, MBE, MBA^\*; Goldman, Mitchel P. MD^†; Fabi, Sabrina MD^†; Kilmer, Suzanne MD^‡; Altmann, Jens MD^§; Mazer, Jean M. MD^||; Samuelson, Ulf MD^¶; Tan, Terence MBBS, MRCS, MMed^\*\*; Ali, Maria PhD^††; Bhogal, Meetu MSc^‡‡; Patel, Vaishali PharmD^§§; Qiao, Hongyan PhD^§§; Karic, Alda PharmD^§§ ### Author Information ^\*Laser & Skin Surgery Center of New York, New York, New York; ^†Cosmetic Laser Dermatology: A Platinum Dermatology Partners Company, San Diego, California; ^‡The Laser & Skin Surgery Medical Group, Inc., Sacramento, California; §BodenseeKLINIK, Lindau, Germany; Centre Laser International de la Peau, Paris, France; ^¶Akademikliniken, Stockholm, Sweden; \*\*Halley Body Slimming Clinic, Singapore; ^††Peloton Advantage, LLC (an OPEN Health Company), Parsippany, New Jersey; ^#‡AbbVie, Toronto, Ontario, Canada; and ^§§Allergan Aesthetics, an AbbVie Company, Irvine, California. Address correspon Street, Suite 1108 Allergan Aesthetic: design, research, a of the publication. review, and approv PhD of Peloton Adv Aesthetics, an Abb Altmann, J. M. Maz an AbbVie Compar study by my institu Health company). Karic is a full-time Jordan V. Wang's c Pennsylvania. Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our Privacy & Cookie Notice 110 East 60th .com. ed in the study Ig, and approval d in the drafting, ided by M. Ali, Allergan ilmer, J. an Aesthetics, Ict this clinical e, LLC (an OPEN of AbbVie. A. sylvania, Devon, The authors have indicated no significant interest with commercial supporters. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided after review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the United States and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://vivli.org/ourmember/abbvie/, then select "Home." This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Dermatologic Surgery ():10.1097/DSS.00000000004797, September 10, 2025. | DOI: 10.1097/DSS.000000000004797 - Open - PAP # Abstract ## BACKGROUND Cryolipolysis is an effective, well-tolerated noninvasive subcutaneous fat reduction treatment. ## OBJECTIVE Assess participant system that can de ## MATERIALS AN Adult participants could also receive point was participa treatment. Second satisfaction with a included 3D imagi initial treatment. S ## RESULTS Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** tor cryolipolysis . Participants Primary end Prinal W, participant ry end points at 4 weeks after Of 110 treated participants, 75% were remark mean age and body mass index were 43 years and 25.1 kg/m², respectively. Of 96 evaluable participants, 83.3% (80/96) were "satisfied/very satisfied" with midsection results. Reviewers correctly identified 88.0% (81/92) of baseline versus 12 weeks after final treatment midsection images. Mean (SD) subcutaneous fat volume loss was 194.8 (492.3) mL at 12 weeks after final treatment (p < .001). Visible improvements were noted at 4 weeks after initial treatment by a majority of physician reviewers and participants. Five (4.5%, 5/110) participants reported 7 treatment-emergent adverse device effects. ## CONCLUSION The dual-applicator cryolipolysis system demonstrated high participant satisfaction, effectiveness, and safety. Among minimally invasive cosmetic procedures, noninvasive fat reduction was the third most-commonly sought procedure from 2021 through 2022.¹ In 2021, 77% of surveyed consumers reported being most bothered by excess body fat.² In addition, a recent US survey of approximately 4000 aesthetically inclined adults interested in improving their body appearance demonstrated that stubborn body fat on the stomach was their most frequent and bothersome concern.³ Cryolipolysis is a noninvasive, clinically proven fat reduction treatment by which controlled cooling extracts heat from subcutaneous tissue to induce selective adipocyte cell death, leading to controlled elimination of adipocytes and reduction in thickness of the subcutaneous fat layer.^4-9 Cryolipolysis treatment is effective and well tolerated over multiple treatment cycles and sessions with high levels of participant satisfaction.^9-11 A new cryolipolysis system using dual applicators with new cup geometries to improve tissue contact was developed to provide simultaneous treatment to >1 body area at any given time and improve treatment efficiency. A retrospective study of 91 patients treated in real-world practice at a single clinic demonstrated high patient satisfaction and comfort with cryolipolysis treatment utilizing the dual-applicato outcomes, effectiv areas is needed. The objectives of t safety of the new ( reduction of the at submental area. # Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** ant-centric ditional body ctiveness, and cutaneous fat hs, and s index of ≥18.5 nd flanks nighs, outer onal body thighs, and/or sub area(s) per investigator assessment. Eligible participants agreed to maintain weight within 5% of body weight at baseline and did not have weight fluctuations >5% in the preceding month. Key exclusion criteria included history of a noninvasive fat reduction procedure and/or body contouring procedure in the area(s) considered for treatment within the past 12 months; history of invasive fat reduction procedure within or adjacent to the area considered for treatment; known sensitivity to cold or history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria; history of surgery, scar tissue, or hernia related to area of treatment; any active implanted device or drugdelivery system within the intended treatment area; a known bleeding disorder or concomitant use of blood thinners (or any medication) associated with an increased risk of bruising; or concomitant use of any diet pills or weight control supplements. This multicenter, multicountry, prospective, open-label, postmarketing study was conducted between May 2021 and June 2022. The study was conducted in compliance with good clinical practice and received institutional review board and ethics committee approval at each site in the United States, France, Sweden, Germany, and Singapore. Participants provided written informed consent. This study is registered at clinicaltrials.gov (NCT#04897867). ## **Treatment Plans** Eligible participants received up to 2 treatment sessions separated by 8 weeks for all body areas eligible for treatment, with a final follow-up visit 12 weeks after final treatment session (week 12 for participants who received 1 treatment session; week 20 for participants who received 2 treatment sessions). Each treatment session comprised $\geq$ 1 cryolipolysis treatment cycle(s) (timed segments of tissue cooling delivered by an applicator) followed by a 2-minute manual massage. The duration of a cryolipolysis # Methods # Participants a Eligible participant and $<30 \text{ kg/m}^2$ an (midsection). If pa treatment cycle is fixed per the design specifications for each applicator according to the device User Manual and ranges from 35 to 75 minutes depending on the applicator chosen for treatment.¹² Treatment plans were designed at the investigator's discretion; upper limits on the number of treatme treatment cycles p that could be adm treatment to the u midsection, ≤4 tre area, for a maximu treatment sessions treatment to the s maximum total of dual-applicator cry Company, Irvine, ( Aesthetics, Inc., ar use (Figure 1). Trea body areas, during same time. Repres # Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our Privacy & Cookie Notice ction, ≤8 reatment cycles to also received to the r each body ed over 2 ceived ermitted, for a es utilized the ics, an AbbVie arks of Zeltiq able for study it of multiple areas at the jure 2. ``` F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 F1 < ``` Image of CoolSculpting Elite system.¹² ©2024 AbbVie. Used with permission. # ₽F2 #### Figure 2.: Representative image of applicator placement in preparation for treatment with CoolSculpting Elite system. Not a study participant; photo is representative. ©2024 AbbVie. Used with permission. ## **Effectiveness and Safety Assessments** The primary effectiveness end point was participant-reported satisfaction with results of cryolipolysis treatment on the midsection as assessed by Item 1 of the Cryolipolysis Satisfaction Questionnaire (CSQ)-Midsection at 12 weeks after final treatment. The CSQ-Midsection is a 2-item patient-reported outcome (PRO) instrument. Item 1 measures participant satisfaction with results of cryolipolysis treatment. The primary end point was met if the proportion of participants who were "satisfied/very satisfied" was $\geq 63.9\%$ , based on previous cryolipolysis studies reporting weighted average participant satisfaction at the midsection. Secondary effectiveness end points included participant-reported satisfaction at 12 weeks after final treatment with the individual treated body areas (upper arms, inner thighs, outer thighs, submental area) on the respective CSQ, and overall satisfaction for participants who completed treatment to the midsection and $\geq 1$ body area(s) to assess satisfaction when multiple body areas are treated. The CSQ-Overall and CSQ specific for body areas are 1-item PRO instruments that measure participant satisfaction with results of treatment when considering all body areas treated and individual body areas, respectively. An additional secondary effectiveness end point was correct identification of baseline versus 12 weeks after final treatment images of the treated body area(s) by $\geq 2$ of 3 blinded, independent physician reviewers; success was defined as $\geq$ 70% correct identification of pretreatment images. A series of baseline and follow-up 2-dimensional (2D) photographs of the treatment areas were taken using a 2D photo capture system (2D Intellistand; Canfield Scientific, Parsippany, NJ). Exploratory effecti changes at 4 and 8 the 3-dimensional imaging system of volumetric change assessments were correct identification body area(s) by $\geq$ : evaluation of notic ## Safety Adverse events (A unanticipated AEs, participant pain wa of 0 (no pain) to 1( treatment, this wa ## **Statistical Analyses** Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our Privacy & Cookie Notice ubcutaneous fat treatment using idy sites. The 3D fication of tory points included f the treated irticipant ADEs, and ent sessions, ment on a scale d during Summary statistics were provided for all analyses, and 2-sided 95% CIs on the percentages were provided. *p* values for change from baseline by visit were provided based on paired *t*-tests. The sample size was planned for the estimate of the primary effectiveness end point based on satisfaction rate for the midsection. Evaluable participants for the primary end point were those who completed their cryolipolysis treatment plan and CSQ-Midsection Item 1 at 12 weeks after final treatment session and did not have any significant protocol deviations or violations. Evaluable participants for other effectiveness end points consisted of all treated participants who completed their cryolipolysis treatment plan for any other body areas with no significant protocol deviations or violations or violations. The safety population consisted of all enrolled participants who received $\geq 1$ cryolipolysis treatment cycle. # Results # **Study Participants** This study was conducted at 8 centers in 5 countries. In total, 114 participants were enrolled, with 4 participants excluded based on an inclusion/exclusion criterion. The safety population comprised 110 participants who were treated and received $\geq 1$ cryolipolysis treatment cycle. All 110 treated participants received treatment to the midsection, and 61 treated participants also were evaluable for an additional body area, comprising the upper arms, inner thighs, outer thighs, and/or submental area. Ninety-nine participants completed the study; 11 participants prematurely discontinued from the study (lost to follow-up, n = 7; withdrawal of consent, n = 1; pregnancy, n = 1; other reasons, n = 2). Three participants were excluded from all evaluable populations due to protocol deviation (weight change from baseline of $\geq$ 5%). Thus, 96 participants were evaluable for the primary end point for the midsection. Baseline characteristics and demographics are summarized in Table 1. TABLE 1. - Baseline Demographics and Characteristics | Age, mean (SD), y
Male, n (%)
Female, n (%)
Body mass index,
Fitzpatrick skin tyj
I
II
III
IV
V
V | Your Privacy we use data collected through these technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our Privacy & Cookie Notice | |-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | *Age relative to inf | | Some participants in the United States (46/57) received a second treatment session >8 weeks after the first treatment session in accordance with a request by the US FDA that occurred during the study period to hold treatment with the dual-applicator cryolipolysis system in the United States until review of a software update was completed. The longer time interval between the first and second treatment sessions was deemed not to adversely impact the analysis of effectiveness outcomes. The primary end point results for these participants were comparable to the overall US population; thus, the data are presented together. ## **Administered Treatment Plans** For the midsection, 97.9% (94/96) of evaluable participants received their prescribed treatment plan over 2 treatment sessions. The mean (SD) number of treatment cycles delivered to the midsection was 13.1 (3.4). Treatment plans were commonly delivered via simultaneous applicator regimens. For the 61 participants who received treatment to an additional body area(s), 85.2% (52/61) of participants received 2 treatment sessions to the respective body area(s). The mean (SD) number of treatment cycles delivered to body areas was 4.9 (1.9) to the combined upper arms (n = 30), 4.7 (2.0) to the combined inner thighs (n = 32), 4.0 (1.4) to the combined outer thighs (n = 4), and 2.9 (1.0) to the submental area (n = 8). The total number of cryolipolysis treatment cycles administered within the study was 1744, comprising all participants and treated body areas. When considering all treated body areas, the average (SD) number of treatment cycles administered per treated participant was 15.8 (5.63). # **Effectiveness End Points** The primary end point was met, with 83.3% (80/96; 95% CI: 74.4, 90.2) of evaluable participants reporting they were "satisfied/very satisfied" with their midsection results on CSQ-Midsection Item 1 at 12 weeks after final treatment session (Figure 3). For participants who were evaluable for midsection and additional body areas, 83.0% (44/53; 95% CI: 70.2, 91.9) of participants reported they were "satisfied/very satisfied" on the CSQ-Overall at 12 both midsection ar individual treated weeks after final tr areas were small ( #### F3 Figure 3.: Response on primary end p questionnaire reported that overall, or for confidence in Photographic iden images demonstra ≥2 out of 3 blinde #### ₽]F4 #### Figure 4.: Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** tive results to action with the ntal areas at 12 respective body the ants tion, rea. Cl, ent midsection ation rate by (A) Correct identification of baseline versus 4 weeks after initial treatment and 12 weeks after final treatment images by at least 2 of 3 blinded, independent physician reviewers. (B) Images of a 29-year-old female participant with baseline BMI of 27.3 kg/m², at pretreatment, 4 and 8 weeks after the first treatment session, and 12 weeks after the second treatment session; participant received 2 treatment sessions with 14 cycles total to the midsection. Participant reported being "satisfied" at 8 weeks after the first treatment and "very satisfied" at 12 weeks after the second treatment on CSQ-Midsection Item 1. ©2024 AbbVie. Used with permission. (C) Images of a 60-year-old female participant with baseline BMI of 23.3 kg/m², at pretreatment, 4 and 8 weeks after the first treatment session, and 12 weeks after the second treatment session; participant received 2 treatment sessions with 14 cycles total to the midsection. Participant reported being "satisfied" on CSQ-Midsection Item 1 at 8 weeks after the first treatment session and 12 weeks after the second treatment session. ©2024 AbbVie. Used with permission. BMI, body mass index; CI, confidence interval; CSQ, cryolipolysis satisfaction guestionnaire. ## **Exploratory Analyses** Three-dimensional images were captured for volumetric analysis for 51% (49/96) of evaluable midsection participants (Figure 5A). Significant midsection subcutaneous fat volume loss from baseline was observed at all time points assessed, including at 4 and 8 weeks after initial treatment and at 12 weeks after final treatment, with an average change from baseline in fat volume of -194.8 mL (p < .001 for each time point vs baseline; Figure 5B). #### F5 Figure 5.: Volumetric subcutaneous fat reduction after cryolipolysis treatment to the midsection (abdomen and flanks). (A) Three-dimensional view of results at 12 weeks after the final treatment session versus pretreatment overlay (shaded); participant re ©2024 AbbVi weeks after ir compared wit .001 versus b Assessment of visi demonstrated a 78 versus 4-week mic reviewers. Most pa 71.7% (76/106) of improvement for a 81.5) of evaluable Variable results we 68.7), 0.0% (0/4: 9 95% CI: 15.7. 84.3 treatment for the i respectively. Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** at 4 and 8 ion me. \*p < -raphic review ate of baseline ysician e point, with ting noticeable i; 95% CI: 62.9, k time point. 95% CI: 31.3, 50.0% (4/8; after initial reas, midsection. ## Analysis of Participants Who Received 2 Treatment Sessions Of the 97.9% (94/96) of evaluable participants who received 2 treatment sessions to the midsection, 84.0% (79/94; 95% CI: 75.0, 90.8) of participants reported they were "satisfied/very satisfied" on CSQ-Midsection Item 1 at 12 weeks after the second treatment session. An additional exploratory analysis on the CSQ-Midsection was performed to observe whether there were trends in satisfaction after the administration of the second treatment session. At 8 weeks after initial treatment session, most participants, 79.8% (75/94), reported being "satisfied/very satisfied," but there were 19 participants who reported that they were "neither satisfied nor dissatisfied" (n = 18) or "dissatisfied" (n = 1). After administration of a second treatment session, 63.2% (12/19) had an improved response and were "satisfied/very satisfied" at 12 weeks after the second treatment session (p < .0001; 95% CI: 0.41, 0.85). For midsection participants who received 2 treatment sessions, the rate of correct identification of baseline versus 4 weeks after initial treatment and 12 weeks after second treatment session midsection photos by $\geq$ 2 out of 3 blinded, independent physician reviewers was 78.5% (73/93; 95% CI: 68.8, 86.3) and 87.8% (79/90; 95% CI: 79.2, 93.7), respectively. In addition, 72.3% (68/94; 95% CI: 62.2, 81.1) reported noticeable improvement at 4 weeks after initial treatment. For the 46 participants who received 2 treatment sessions and had analyzable 3D photos, the mean (SD) change in volume of subcutaneous fat from baseline was -114.0 (270.1) mL at 4 weeks after initial treatment session, -155.6 (333.7) mL at 8 weeks after initial treatment session, and -217.0 (483.6) mL at 12 weeks after second treatment session (p < .001 for vs baseline for all time points). ## Safety Of 110 treated participants, 9 (8.2%) participants reported 12 treatment-emergent adverse events (TEAEs). All TEAEs were mild and resolved by the end of the study; none led to study discontinuation. Of 12 TEAEs, 7 were considered device-related TEAEs and were reported by ! emergent adverse The 7 TEADEs wer tenderness (n = 2) within 1 day. Four and 1 case of abdor resolved before th reported the event in the second treat treatment sessions study period and r During the treatment the second treatment areas except for the treatment for both treatment session # Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** atment- , abdominal ziness resolved to 3 weeks, ted to be (1.8%, 2/110) rted the event in both orted during the ecorded during all treated body vith submental ) and second in scores reported during the first and second treatment sessions of the midsection were 3.6 (2.2) and 4.0 (2.6), respectively. At the 12-week follow-up/exit visit, no participants reported pain. There were no treatment discontinuations or interruptions due to pain. # Discussion This was the first prospective, global, multicountry study to assess treatment outcomes with a new dual-applicator cryolipolysis system for the midsection and additional body areas. This study showed that cryolipolysis treatment achieved the aesthetic goals of participants and met the primary study objective, with high levels of participant satisfaction with the treatment results to the midsection. In addition, visible results were observed by blinded, independent physician reviewers at 4 weeks after initial treatment session and 12 weeks after final treatment session. Results of this study are consistent with prior cryolipolysis studies.^9-11 A prospective postmarketing study demonstrated high participant satisfaction after treatment of the midsection with a single-applicator cryolipolysis system,¹⁰ and effectiveness and high participant satisfaction were reported in a separate study with multiple overlapping cycles and multiple treatment sessions to the midsection, upper arms, and submental area.⁹ A single-center retrospective study with the same dual-applicator cryolipolysis system used in this trial also demonstrated high participant satisfaction, suggesting that the results achieved in real-world clinical practice are consistent with those reported in clinical trials.¹¹ The variety of treatment cycle regimens administered within the present study indicates that the study investigators tailored treatment plans to meet individual participants (97.9%) received treatment plans comprising 2 treatment sessions, which is consistent with a prior study indicating that 2 treatment sessions were the most commonly prescribed treatment plan for the abdomen and flanks when investigators were allowed to use 1 or 2 treatment sessions.¹⁰ The average number of treatment cycles (13.1) delivered to the midsection was also comparable with recent recommendations from a global expert panel on cryolipolysis treatment.¹³ The exploratory analysis of participants who received 2 treatment exceives indicated that for nation's who are participants who re neutral or dissatist may increase the l trend is needed. Your Privacy The 4-week after in early anecdotal feat who noticed improreported noticeabl body areas, and in addition, objective imaging of the mic This study allowed outer thighs, and s may be seeking tr cryolipolysis treatr the participants wl To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** atment session iluation of this his study given olysis system, rticipants of the treated vely). In and 3D point. ns, inner thighs, n which patients is guidelines for treatment.¹³ Of Jable for additional body area(s), 83% (44/53) were "satisfied/very satisfied" with their results when considering all treated body areas. The focus of this study was the midsection and treatment of additional body areas was optional, so the number of participants per individual additional body area was small; therefore, limited conclusions can be made when assessing nonmidsection results. Generally, higher levels of participant satisfaction were reported for treatment of the upper arms and submental area than the inner and outer thighs. With a sum total of 1744 treatment cycles across all treatment plans administered during the study and the capability for simultaneous treatment with multiple applicators, cryolipolysis treatment with the dual-applicator system was well tolerated. No new safety signals emerged. Treatment-emergent adverse device effects were mild and resolved within days to weeks. There were no unanticipated AEs or SAEs reported in this study. Most mean pain scores were $\leq$ 5.5 during the treatment sessions and follow-up time points. Limitations of the study include lack of a control group and randomization. In addition, the precision of volume changes observed with 3D image analysis may have been affected by the size and variability of area of interest for the image capture technique, and changes in posture, hand positioning, and clothing worn at the time of imaging. Standard deviations with the same magnitude of difference were reported previously in this setting.¹⁰ Furthermore, there was no participant cost for receiving treatment, which has the potential to introduce bias when participants evaluate treatment outcomes. Finally, for countries in which race/ethnic background information could be collected, there were a limited number of participants identifying as non-White; future studies with increased diversity of participants are needed. # Conclusions This first global, prospective, multicountry clinical study of the recently launched dualapplicator cryolipolysis system demonstrated high participant satisfaction, effectiveness, and safety, with the capability of providing simultaneous treatment. This study builds on the evidence from prior cryolipolysis studies by demonstrating high participant satisfaction with treatment to the midsection and other body areas. Objective measurements de physicians as early 3D imaging also de safety signals were # Acknowled The authors thank this study and pub # References 1. American Sociel Cosmetic Surgery https://www.plastic surgery-2022.pdf. • Cited Here 2. American Society for Dermatological Surgery. 2021 ASDS Consumer Survey on Cosmetic Dermatologic Procedures. American Society for Dermatological Surgery; 2022. Available from: https://www.asds.net/medical-professionals/practice-resources/consumer- survey-on-cosmetic-dermatologic-procedures. Accessed March 22, 2023. • Cited Here 3. Zeidler KR, Moradi A, Woolery-Lloyd H, Sherber N, et al. Aesthetic Concerns and Interests Surrounding Facial and Body Appearance: A Large Survey Among a Diverse, Aesthetically-Inclined Population in the United States [Oral Presentation]. Presented at: The Aesthetic Meeting; April 21-23, 2023; Miami Beach, FL, USA. - Cited Here | - Google Scholar 4. Boey GE, Wasilenchuk JL. Fat reduction in the inner thigh using a prototype cryolipolysis applicator. Dermatol Surg 2014;40:1004–9. - Cited Here | - Google Scholar 5. Bernstein EF, Bloom JD, Basilavecchio LD, Plugis JM. Non-invasive fat reduction of the flanks using a new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers Surg Med 2014;46:731–5. - Cited Here | - Google Scholar Your Privacy To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our **Privacy & Cookie Notice** tributions to v blinded inal treatment. ction. No new ds Report: lable from: t-cosmetic- 6. Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, et al. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med 2014;46:75–80. Your Privacy - Cited Here | - Google Schol 7. Kilmer SL, Burns reduction of subm - Cited Here - Google Schola 8. Friedmann DP. C with a nonvacuum - Cited Here - Google Schola 9. McKeown DJ, Pa CoolSculpting: res - Cited Here | - Google Schola To give you the best possible experience we use cookies and similar technologies. We use data collected through these technologies for various purposes, including to enhance website functionality, remember your preferences, show the most relevant content, and show the most useful ads. You can select your preferences by clicking the link. For more information, please review our Privacy & Cookie Notice or non-invasive ical abdomen 5:1185–90. Itiple cycles of 350. 10. Tan T, Snell B, Braun M, Mohan S, et al. High participant satisfaction achieved using cryolipolysis for fat reduction of the abdomen and flanks. Aesthet Surg J 2022;42:760–70. - Cited Here - Google Scholar 11. Altmann J, Jehle F, Mang W. Patient satisfaction, recommendation rate, and patient comfort with an FDA-cleared cryolipolysis system. Aesthet Surg J Open Forum 2022;4:ojac067. - Cited Here - Google Scholar 12. CoolSculpting Elite System User Manual (United States). Pleasanton, CA: Zeltiq Aesthetics, Inc; 2021. • Cited Here 13. Altmann J, Burns AJ, Kilmer SL, Lee C, et al. Global expert opinion on cryolipolysis treatment recommendations and considerations: a modified Delphi study. Aesthet Surg J Open Forum 2022;4:ojac008. - Cited Here | - Google Scholar Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc. View full article text # **Readers Of this Article Also Read** Your Privacy - Regenerative Skincare Technologies Derived From Human Fibroblasts: Growth... - Nonablativ 1927 nm) - Minimally Feelings o - A Random Comparing # Investigat Anesthesia ∧Back to Top Current Issue Co ### Never Miss an Is similar technologies. 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