Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Completed · Not applicable
Conditions studied: Cellulite
In brief
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
Key facts
- Study ID
- NCT03981198
- Run by
- Soliton
- People needed
- 10
- Starts
- 2018-07-31
- Expected to finish
- 2019-08-05
- Last updated by the study team
- 2021-09-28
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
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.)
Where it is running
- SkinCare Physicians — Chestnut Hill, Massachusetts, United States
Full record on ClinicalTrials.gov
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