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

NCT ID: NCT03981198

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-08-05

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).

Conditions

Cellulite

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

RAP treatment

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

Group Type: OTHER

Soliton Rapid Acoustic Pulse (RAP)

Intervention Type: DEVICE

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

Interventions

Soliton Rapid Acoustic Pulse (RAP)

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

Intervention Type: DEVICE

Other Intervention Names

RAP

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Soliton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher C Capelli, MD

Role: STUDY_DIRECTOR

Soliton

Locations

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Countries

United States

Other Identifiers

Soliton 2018-001

Identifier Type: -

Identifier Source: org_study_id