Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Visit 1: Baseline/Screening (-30 Days to Day 0) Visit 2: Treatment (Day 0) Visit 3: 12-week Follow-Up Visit (+/- 14 Days) Visit 4: 26-week Follow-Up Visit (+/- 14 Days) (Optional) Visit 5: 52 Week Follow-Up Visit (+/- 14 Days) (Optional)

Official Title
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A Single Center Prospective Study to Evaluate the Safety and Effectiveness of the Soliton® Rapid Acoustic Pulse (RAP)™Device for the Improvement in the Appearance of Cellulite.

Conditions
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Cellulite

Intervention / Treatment
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* Device: RAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking treatment of cellulite in the thigh and/or buttock areas Area of moderate to severe cellulite on thigh and/or buttock for both legs using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial. Body Mass Index (B.M.I.) is ≤ 30 Participant will not have had invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months. Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial. Participant will not have used spray-on tanning treatments for 6 months prior to the initiation of the trial. Furthermore, participants will not use spray-on tanning treatments during the term of the trial. Participants must be able to provide written informed consent, understand and is willing to comply with all study related procedures and follow-up visits. Exclusion Criteria: Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers. Participant is pregnant or planning to become pregnant during the duration of the study. Participant is unwilling to commit to follow-up visits Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.). Active electronic implants such as pacemakers, defibrillators. History of coagulopathy(ies) and/or on anticoagulant medication. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study. Participant is a current smoker. Participant has tattoo in treatment area.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Each leg/buttock will be treated with the RAP device<br>Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz | Device: RAP<br>* Treatment of cellulite with RAP device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |