Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] · 2025
Participant Satisfaction, Effectiveness, and Safety With a Novel Dual-Applicator Cryolipolysis System: A Prospective, Multicountry Study.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Geronemus Roy G, Wang Jordan V, Goldman Mitchel P, Fabi Sabrina, Kilmer Suzanne, Altmann Jens, Mazer Jean M, Samuelson Ulf, Tan Terence, Ali Maria, Bhogal Meetu, Patel Vaishali, Qiao Hongyan, Karic Alda
Аннотация
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.
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.