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

Primary Purpose

Cellulite

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RAP
Sponsored by
Soliton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • The Practice of Brian Biesman

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Each leg/buttock will be treated with the RAP device

Arm Description

Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 22, 2021
Last Updated
May 1, 2023
Sponsor
Soliton
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1. Study Identification

Unique Protocol Identification Number
NCT05199506
Brief Title
Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soliton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Each leg/buttock will be treated with the RAP device
Arm Type
Experimental
Arm Description
Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz
Intervention Type
Device
Intervention Name(s)
RAP
Intervention Description
Treatment of cellulite with RAP device
Primary Outcome Measure Information:
Title
Assessing safety
Description
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
Time Frame
Immediately post treatment
Title
Assessing safety
Description
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.
Time Frame
12 weeks post treatment
Title
Assessing Efficacy
Description
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.
Time Frame
At 12 week follow up visit
Secondary Outcome Measure Information:
Title
Assessing Participant Satisfaction
Description
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.
Time Frame
At the 12 week follow up visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Capelli, MD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
The Practice of Brian Biesman
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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