A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants

Study Overview
=================
Brief Summary
-----------------
Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of cottage cheese or an orange peel. Rapid Acoustic Pulse (RAP) is an electrohydraulic (EH) device developed to improve the appearance of cellulite through microscopic disruption of the connection between the skin and underlying tissue leading to a reduction in the severity of dimples and ridges. The purpose of this study is to assess adverse events and effectiveness of RAP in adults seeking treatment of cellulite. RAP is an FDA approved device for the short-term improvement in the appearance of cellulite in the buttocks and thighs. Participants 18-50 years of age seeking treatment of cellulite will be enrolled. Up to 15 participants will be enrolled in the study at 1 site in the United States. Participants will receive 3 separate cellulite treatment sessions. Each treatment session will consist of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides. The study duration is up to 72 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Official Title
-----------------
A Single-Center, Prospective Study to Evaluate the Safety and Effectiveness of Multi-Treatment Regimen With Zeltiq Aesthetics, Inc. Rapid Acoustic Pulse (RAP)™ Device for the Improvement in the Appearance of Cellulite

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

Intervention / Treatment
-----------------
* Device: Rapid Acoustic Pulse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants seeking treatment of cellulite in the thigh and/or buttock areas. Areas of moderate to severe cellulite on bilateral thigh and/or buttock 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. Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months. Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial. Exclusion Criteria: Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas. Active electronic implants such as pacemakers, defibrillators History of coagulopathy and/or on anticoagulant medication Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas. Medical disorder that would hinder wound healing or immune response. Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study. Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.

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

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

Accepts Healthy Volunteers
-----------------
No

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: Rapid Acoustic Pulse (RAP)<br>Participants will receive 3 separate RAP cellulite treatments sessions. | Device: Rapid Acoustic Pulse<br>* Subcutaneous Rapid Acoustic Pulse Treatments<br>* Other names: RAP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR) | The number of before and after side-by-side photographs correctly identified by at least 2 of 3 blinded reviewers from the IPR panel. | Week 24 | 
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered by a medical device which does not necessarily have a causal relationship with the treatment. | 72 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Agree or Strongly Agree Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite | The study participant demonstrates improvement by selecting ''Agree or Strongly Agree as answers to the Participant Satisfaction Survey statement - 'In comparison to the pre-treatment photo, the 12 week photograph of the treatment area appears improved.' | Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rapid Acoustic Pulse, RAP, Cellulite