NCT05358847

Treatment for Cellulite Appearance

Safety and Efficacy of Sofwave Treatment for Improvement of Cellulite Appearance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Detailed description

Eligible patients will receive 2 treatments (4-6 weeks apart) on one side (right or left) of the lateral/ posterior upper thigh / buttocks using Sofwave System. Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visits at 3 months ± 3 weeks post last treatment (FU1). Optionally, additional follow-up visit will be conducted 6 (± 4 weeks) months following end of treatment (FU2). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Conditions

• Cellulite

Interventions

Type	Name	Description
DEVICE	Sofwave	The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.

Timeline

• Start date: 2021-11-21
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-05-03
• Last updated: 2023-11-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study