Cellulite
Conditions
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).
Interventions
DEVICESoliton Rapid Acoustic Pulse (RAP)
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
Sponsors
Soliton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single Group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SAEs | 18 weeks | The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit. |
| Treatment Tolerability | 18 Weeks | The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is \< 8.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cellulite improvement | 18 weeks | A ≥15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment. |
Countries
United States
Outcome results
None listed