Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite

Study Overview
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Brief Summary
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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
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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).

Official Title
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Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite

Conditions
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Cellulite

Intervention / Treatment
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* Device: Soliton Rapid Acoustic Pulse (RAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female ages 18-65 years Participant seeking treatment of cellulite in the upper lateral thigh areas Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A) Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30 Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up Participant is willing to participate in study and adhere to follow-up schedule Participant is able to read and comprehend English Participant has completed Informed Consent Form Exclusion Criteria: Participant is pregnant or planning to become pregnant during the duration of the study Participant has a BMI > 30 Greater than 10% increase or decrease in body weight within past 6 months Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure) 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, cochlear implants, nerve/brain stimulators, drug pump, etc. Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite. Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RAP treatment<br>Single RAP treatment applied to thigh and multi-treatment applied to the other thigh. | Device: Soliton Rapid Acoustic Pulse (RAP)<br>* Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.<br>* Other names: RAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SAEs | The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit. | 18 weeks | 
| Treatment Tolerability | The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0 | 18 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellulite improvement | A ≥15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment. | 18 weeks |