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

NCT03981198 | Completed FDA Device

• 1 other identifier: Soliton 2018-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Cellulite

Outcome Measures

Primary Outcomes (2)

• 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.

  18 weeks

• Treatment Tolerability

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

  18 Weeks

Secondary Outcomes (1)

• Cellulite improvement

  18 weeks

Study Arms (1)

RAP treatment

OTHER

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

Device: Soliton Rapid Acoustic Pulse (RAP)

Interventions

Soliton Rapid Acoustic Pulse (RAP) DEVICE

Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.

Also known as: RAP

RAP treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Soliton: lead

Study Sites (1)

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher C Capelli, MD

  Soliton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 10, 2019
• Study Start: July 31, 2018
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)