Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

NCT04065711 | Completed FDA Device

• 1 other identifier: 2019-002
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• Procedure Safety- All treated participants are free from unexpected adverse events

  The primary objective is to demonstrate freedom from unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment.

  12 weeks

Secondary Outcomes (1)

• RAP treatment effectiveness

  12 weeks, 26 weeks and 52 weeks

Study Arms (1)

RAP Treatment

EXPERIMENTAL

Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment.

Device: Soliton's Rapid Acoustic Pulse (RAP)

Interventions

Soliton's Rapid Acoustic Pulse (RAP) DEVICE

Treatment for the temporary improvement in the appearance of cellulite.

RAP Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: This study is specific to females ages 18-50 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female ages 18-50 years
• Seeking treatment of cellulite in the thigh and/or buttock areas
• Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
• Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
• Stable weight nominally +/- 5% for at least the past 6 months.
• 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.
• Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment.
• Participant is willing to participate in study and adhere to follow-up schedule
• Participant is able to read and comprehend English
• Participant has completed the Informed Consent Form

You may not qualify if:

• 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.
• Has atrophic scars, or has a history of atrophic scars or keloids.
• Tattoo or former tattoo at or near treatment area.
• 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.
• Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.).
• History of coagulopathy(ies) and/or on anticoagulant medication.
• Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
• Current smoker.
• Any surgical procedure in the prior 3 months, or planned during the duration of the study.

Sponsors & Collaborators

• Soliton: lead

Study Sites (4)

Clear Dermatology and Aesthetics Center Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Chicago Cosmetic Surgery & Dermatology

Chicago, Illinois, 60654, United States

Location

Capital Laser and Skin Care

Chevy Chase, Maryland, 20815, United States

Location

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 Capelli, MD

  Soliton, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: July 20, 2019
• Primary Completion: July 20, 2021
• Study Completion: August 26, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)