NCT06724146

Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance

Safety and Efficacy of Upper Arm Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Eligible patients will receive combined treatment on both upper arms, included 1 or 2 SofWave treatments and 4 Pure Impact treatments. At the first session (Visit 1), subjects undergo SofWave treatment, and may undergo Pure Impact treatment also at the same visit. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the Pure Impact 2-7 days after the SofWave procedure. If the two treatments are conducted on the same day, then the second Pure Impact session will be 7-10 days after; similarly, the third and fourth Pure Impact sessions will be performed 7-10 days apart following the previous session. The last (fourth) Pure Impact treatment may occur on the same day or after the optional second SofWave treatment. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the SofWave 2-7 days after the fourth Pure Impact procedure. All patients will return to the clinic for two follow-up visits at 4±1 weeks and at 12±2 weeks post last treatment (FU1 and FU2).

Conditions

• Skin Lax and Muscle Strength

Interventions

Type	Name	Description
DEVICE	Sofwave and Pure Impact	The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.

Timeline

• Start date: 2024-08-05
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2024-12-09
• Last updated: 2024-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study