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Clinical Trial
. 2026 Jan 1;52(1):61-68.
doi: 10.1097/DSS.0000000000004797. Epub 2025 Sep 10.

Participant Satisfaction, Effectiveness, and Safety With a Novel Dual-Applicator Cryolipolysis System: A Prospective, Multicountry Study

Roy G Geronemus  1 , Jordan V Wang  1 , Mitchel P Goldman  2 , Sabrina Fabi  2 , Suzanne Kilmer  3 , Jens Altmann  4 , Jean M Mazer  5 , Ulf Samuelson  6 , Terence Tan  7 , Maria Ali  8 , Meetu Bhogal  9 , Vaishali Patel  10 , Hongyan Qiao  10 , Alda Karic  10
Affiliations
Clinical Trial

Participant Satisfaction, Effectiveness, and Safety With a Novel Dual-Applicator Cryolipolysis System: A Prospective, Multicountry Study

Roy G Geronemus et al. Dermatol Surg. .

Abstract

Background: Cryolipolysis is an effective, well-tolerated noninvasive subcutaneous fat reduction treatment.

Objective: Assess participant satisfaction, effectiveness, and safety of a dual-applicator cryolipolysis system that can deliver simultaneous treatments.

Materials and methods: Adult participants received treatment to the abdomen/flanks (midsection). Participants could also receive treatment to upper arms, thighs, and submental area. Primary end point was participant satisfaction with midsection results at 12 weeks after final treatment. Secondary end points included independent photography review, participant satisfaction with additional body areas, and overall satisfaction. Exploratory end points included 3D imaging of midsection volumetric changes and assessments at 4 weeks after initial treatment. Safety was monitored throughout.

Results: Of 110 treated participants, 75% were female. Mean age and body mass index were 43 years and 25.1 kg/m 2 , 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.

Trial registration: ClinicalTrials.gov NCT#0489786.

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Conflict of interest statement

Jordan V. Wang's current affiliation is Laser & Skin Surgery Center of Pennsylvania, Devon, Pennsylvania.

The authors have indicated no significant interest with commercial supporters.

Figures

Figure 1.
Figure 1.
Image of CoolSculpting Elite system. ©2024 AbbVie. Used with permission.
Figure 2.
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.
Figure 3.
Figure 3.
Response on CSQ item 1 for individual body areas (midsection being the primary end point) and overall (midsection plus other body area[s]) questionnaires at 12 weeks after final treatment session. No participants reported that they were “very dissatisfied” on CSQ Item 1 for midsection, overall, or for inner thighs, outer thighs, upper arms, or submental area. CI, confidence interval; CSQ, Cryolipolysis Satisfaction Questionnaire.
Figure 4.
Figure 4.
(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 questionnaire.
Figure 5.
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 received 2 treatment sessions with 14 cycles total to the midsection. ©2024 AbbVie. Used with permission. (B) Mean volumetric changes at 4 and 8 weeks after initial treatment and 12 weeks after final treatment session compared with baseline; negative change indicates reduction in volume. *p < .001 versus baseline; aSD = 265.0; bSD = 335.4 mL; cSD = 492.3 mL.
See this image and copyright information in PMC

References

    1. American Society of Plastic Surgeons. Inaugural ASPS Insights and Trends Report: Cosmetic Surgery 2022. American Society of Plastic Surgeons. 2022. Available from: https://www.plasticsurgery.org/documents/News/Trends/2022/trends-report-.... Accessed March 22, 2023.
    1. 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-s.... Accessed March 22, 2023.
    1. 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.
    1. Boey GE, Wasilenchuk JL. Fat reduction in the inner thigh using a prototype cryolipolysis applicator. Dermatol Surg 2014;40:1004–9. - PubMed
    1. 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. - PMC - PubMed

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