Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss
NCT07685834 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-07-08
Summary
Open-label, randomized double-arm prospective, single-center, self-controlled clinical study.
Conditions
- Lax Skin
Interventions
- DEVICE
-
SUPERB
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.
Sponsors & Collaborators
-
Sofwave Medical LTD
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-27
- Primary Completion
- 2027-03-01
- Completion
- 2027-03-01
Countries
- Canada
Study Locations
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