NCT05882721

Treatment for Improvement of Cellulite Appearance Using Form Applicator

Safety and Efficacy of SofWave Treatment for Improvement of Cellulite Appearance Using

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (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 ± 2 weeks apart) on either one side (right or left) or both sides of the lateral/posterior upper thigh and/or buttocks using SofWave System with the Form applicator ('2X'). 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 visit at 3 months ± 1 week post last treatment (FU1). 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. Other Names: SUPERB

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-11-01
• Completion: 2023-11-15
• First posted: 2023-05-31
• Last updated: 2023-11-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study