Trials / Completed
CompletedNCT06104514
Safety and Efficacy of SofWave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids
Safety and Efficacy of Sofwave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Sofwave Medical LTD · Industry
- Sex
- All
- Age
- 35 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
Open-label, non-randomized, prospective, multi-center, self-controlled
Detailed description
Patients will receive 2 monthly treatments with the SofWave system and will be followed up twice: at 4 weeks and 12 weeks after last treatment (FU1-FU2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2025-05-12
- Completion
- 2025-05-12
- First posted
- 2023-10-27
- Last updated
- 2025-05-15
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06104514. Inclusion in this directory is not an endorsement.