Trials / Completed
CompletedNCT03981198
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Soliton · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
Detailed description
To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Soliton Rapid Acoustic Pulse (RAP) | Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite. |
Timeline
- Start date
- 2018-07-31
- Primary completion
- 2019-08-05
- Completion
- 2019-08-05
- First posted
- 2019-06-10
- Last updated
- 2021-09-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03981198. Inclusion in this directory is not an endorsement.