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

Primary Purpose

Cellulite

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

About this trial

This is an interventional device feasibility trial for Cellulite

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • SkinCare Physicians

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RAP treatment

Arm Description

Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.

Outcomes

Primary Outcome Measures

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.
Treatment Tolerability
The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0

Secondary Outcome Measures

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.

Full Information

First Posted
May 31, 2019
Last Updated
September 22, 2021
Sponsor
Soliton
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1. Study Identification

Unique Protocol Identification Number
NCT03981198
Brief Title
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Official Title
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (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
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
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).

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
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAP treatment
Arm Type
Other
Arm Description
Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.
Intervention Type
Device
Intervention Name(s)
Soliton Rapid Acoustic Pulse (RAP)
Other Intervention Name(s)
RAP
Intervention Description
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
Primary Outcome Measure Information:
Title
Incidence of SAEs
Description
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.
Time Frame
18 weeks
Title
Treatment Tolerability
Description
The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0
Time Frame
18 Weeks
Secondary Outcome Measure Information:
Title
Cellulite improvement
Description
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.
Time Frame
18 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher C Capelli, MD
Organizational Affiliation
Soliton
Official's Role
Study Director
Facility Information:
Facility Name
SkinCare Physicians
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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