Trials / Completed
CompletedNCT04016610
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment Using Rapid Acoustic Pulse (RAP) Device for the Treatment of Keloid Scar
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Soliton · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.
Detailed description
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Soliton's Acoustic Scar Reduction (SAR) | Treatment of keloid scars for the temporary improvement in appearance. |
Timeline
- Start date
- 2019-07-09
- Primary completion
- 2020-02-12
- Completion
- 2020-02-12
- First posted
- 2019-07-11
- Last updated
- 2021-09-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04016610. Inclusion in this directory is not an endorsement.