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

Primary Purpose

Cellulite

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rapid Acoustic Pulse
Sponsored by
Zeltiq Aesthetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite focused on measuring Rapid Acoustic Pulse, RAP, Cellulite

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Innovation Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rapid Acoustic Pulse (RAP)

Arm Description

Participants will receive 3 separate RAP cellulite treatments sessions.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.'

Full Information

First Posted
December 15, 2022
Last Updated
January 17, 2023
Sponsor
Zeltiq Aesthetics
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1. Study Identification

Unique Protocol Identification Number
NCT05664581
Brief Title
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite
Keywords
Rapid Acoustic Pulse, RAP, Cellulite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapid Acoustic Pulse (RAP)
Arm Type
Experimental
Arm Description
Participants will receive 3 separate RAP cellulite treatments sessions.
Intervention Type
Device
Intervention Name(s)
Rapid Acoustic Pulse
Other Intervention Name(s)
RAP
Intervention Description
Subcutaneous Rapid Acoustic Pulse Treatments
Primary Outcome Measure Information:
Title
Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR)
Description
The number of before and after side-by-side photographs correctly identified by at least 2 of 3 blinded reviewers from the IPR panel.
Time Frame
Week 24
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
72 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants with "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite
Description
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.'
Time Frame
Week 24

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Akbari
Phone
19252416297
Email
clinicalstudy@pleasantonirc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeltiq Aesthetics
Organizational Affiliation
Zeltiq Aesthetics
Official's Role
Study Director
Facility Information:
Facility Name
Innovation Research Center
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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