Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Soliton
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).
Age
18–65
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible 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 be 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.)
Clareo Health | Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
