Safety and Efficacy of SofWave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids
NCT06104514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-05-15
Summary
Open-label, non-randomized, prospective, multi-center, self-controlled
Conditions
- Rhytides
- Wrinkle
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.
Sponsors & Collaborators
-
Sofwave Medical LTD
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 35 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2025-05-12
- Completion
- 2025-05-12
- FDA Device
- Yes
Countries
- United States
Study Locations
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