Status:
COMPLETED
Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite
Lead Sponsor:
Soliton
Conditions:
Cellulite
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
The purpose of this single site clinical study is to evaluate the safety and effectiveness of the Soliton Rapid Acoustic Pulse (RAP) device for the improvement of cellulite comparing two different RAP...
Detailed Description
This is a non-significant risk, single-center, prospective trial for safety, and efficacy using Soliton's RAP device for the improvement in the appearance of cellulite performed at 1 (one) clinical re...
Eligibility Criteria
Inclusion
- Seeking treatment of cellulite in the thigh and/or buttock areas
- Area of moderate to severe cellulite on thigh and/or buttock for both legs using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
- Body Mass Index (B.M.I.) is ≤ 30
- Participant will not have had invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
- Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
- Participant will not have used spray-on tanning treatments for 6 months prior to the initiation of the trial. Furthermore, participants will not use spray-on tanning treatments during the term of the trial.
- Participants must be able to provide written informed consent, understand and is willing to comply with all study related procedures and follow-up visits.
Exclusion
- Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
- Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
- Participant is pregnant or planning to become pregnant during the duration of the study.
- Participant is unwilling to commit to follow-up visits
- 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.
- History of coagulopathy(ies) and/or on anticoagulant medication.
- Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
- Participant is a current smoker.
- Participant has tattoo in treatment area.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05199506
Start Date
May 4 2021
End Date
July 28 2022
Last Update
May 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Practice of Brian Biesman
Nashville, Tennessee, United States, 37203