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ACTIVE NOT RECRUITING
NCT07685821
NA

In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave Treatment

Sponsor: Sofwave Medical LTD

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

35 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-12-22

Completion Date

2026-12

Last Updated

2026-07-06

Healthy Volunteers

Yes

Interventions

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. 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.

Locations (1)

Dermatology Cosmetic Laser Associates of La Jolla, Inc

San Diego, California, United States