Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.

Detailed Description
-----------------
Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.

Official Title
-----------------
Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

Conditions
-----------------
Cellulite

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female ages 18-50 years Seeking treatment of cellulite in the thigh and/or buttock areas Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2) Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater. Stable weight nominally +/- 5% for at least the past 6 months. 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. Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment. Participant is willing to participate in study and adhere to follow-up schedule Participant is able to read and comprehend English Participant has completed the Informed Consent Form 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. Has atrophic scars, or has a history of atrophic scars or keloids. Tattoo or former tattoo at or near treatment area. 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. Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.). History of coagulopathy(ies) and/or on anticoagulant medication. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. Current smoker. Any surgical procedure in the prior 3 months, or planned during the duration of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAP Treatment<br>Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment. | Device: Soliton's Rapid Acoustic Pulse (RAP)<br>* Treatment for the temporary improvement in the appearance of cellulite.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Safety- All treated participants are free from unexpected adverse events | The primary objective is to demonstrate freedom from unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAP treatment effectiveness | To demonstrate temporary improvement in the appearance of cellulite as determined by blinded independent physician assessment (IPA) correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. | 12 weeks, 26 weeks and 52 weeks |