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

Soliton

Status: Completed

Conditions: Cellulite

Treatments: Device: Soliton Rapid Acoustic Pulse (RAP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03981198

Soliton 2018-001

Details and patient eligibility

About

Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite

Full 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).

Enrollment: 10 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts 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.)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

RAP treatment

Other group

Description:

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

Treatment:

Device: Soliton Rapid Acoustic Pulse (RAP)