NCT05358327

Treatment for Lifting Upper Arm Lax Skin

Safety and Efficacy of Sofwave Treatment to Lift Upper Arm Lax Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: All
• Age: 35 Years – 70 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 on both upper arms (4-6 weeks apart) using the 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 follow up visit at 3 months ± 2 weeks 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

• Lax Skin

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: 2022-05-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-05-03
• Last updated: 2023-11-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study