Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss

NCT07685834 · Active, not recruiting

Last updated 2026-07-13

This clinical trial is testing whether SofWave treatment can improve loose skin in adults who are starting a weight-loss medication called tirzepatide.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 30 people Planned (estimated).

Who can join Ages 30–50 · female only Healthy volunteers accepted.

Timeline Started 2026-02 · est. completion 2027-03

Where 1 site · Canada

What this study is testing ClinicalTrials.gov NCT07685834 ↗

Description as written by the study sponsor.

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

Treatments tested

SUPERB Device

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.

Main thing measured	Improvement in the appearance of lax skin
Sponsor	Sofwave Medical LTD
Conditions studied	Lax Skin
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07685834 ↗