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The purpose of this single site clinical study is to evaluate the safety and effectiveness of the Soliton Rapid Acoustic Pulse (RAP) device for the improvement of cellulite comparing two different RAP treatment doses.
This is a non-significant risk, single-center, prospective trial for safety, and efficacy using Soliton's RAP device for the improvement in the appearance of cellulite performed at 1 (one) clinical research site in the United States.
Approximately 15 healthy female participants between the age of 18-55 inclusive will be enrolled in this study.
Participants who sign the informed consent form and meet all the eligible criteria will be enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on each of the participants buttocks and legs. The participant's right buttock and leg will receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.
Total study duration is anticipated to be at or less than 55 weeks from the first participant visit to the last participant observation visit. A total of 3 visits, plus two optional visits are planned for this study as listed below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Each leg/buttock will be treated with the RAP device | Experimental | Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAP | Device | Treatment of cellulite with RAP device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing safety | The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment immediately post-treatment | Immediately post treatment |
| Assessing safety | The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment at the short-term (12-week) visit. | 12 weeks post treatment |
| Assessing Efficacy | The primary effectiveness objective was to demonstrate improvement in the appearance of cellulite from the 100 Hz treatment is comparable to the 50 Hz treatment. Efficacy determined by the results of a blinded independent physician assessment (IPA) panel correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs for both treatments. The primary effectiveness endpoint will be met if the rate of correctly identified before and after photos for 100 Hz treatment is not significantly lower than the 50 Hz treatment assessment. | At 12 week follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing Participant Satisfaction | Improvement in cellulite as measured by the percentage of participants who agree or strongly agree that the final photograph of the treatment area as compared to the baseline photograph, appears improved. | At the 12 week follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Capelli, MD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Practice of Brian Biesman | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37694399 | Derived | Biesman BS, Capelli CC. Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite. Lasers Surg Med. 2024 Jan;56(1):32-38. doi: 10.1002/lsm.23718. Epub 2023 Sep 11. |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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