An interventional study of RAP in Cellulite, sponsored by Soliton. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Soliton · Not applicable, Interventional, and Treatment
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 treatment doses.
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 research site in the United States.
Approximately 15 healthy female participants between the age of 18-55 inclusive will be enrolled in this study.
Participants who sign the informed consent form and meet all the eligible criteria will be enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on each of the participants buttocks and legs. The participant's right buttock and leg will receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.
Total study duration is anticipated to be at or less than 55 weeks from the first participant visit to the last participant observation visit. A total of 3 visits, plus two optional visits are planned for this study as listed below:
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 15 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Soliton is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz
Device: RAP
Treatment of cellulite with RAP device
Assessing safety
The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment immediately post-treatment
Time frame: Immediately post treatment
Assessing safety
The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment at the short-term (12-week) visit.
Time frame: 12 weeks post treatment
Assessing Efficacy
The primary effectiveness objective was to demonstrate improvement in the appearance of cellulite from the 100 Hz treatment is comparable to the 50 Hz treatment. Efficacy determined by the results of a blinded independent physician assessment (IPA) panel correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs for both treatments. The primary effectiveness endpoint will be met if the rate of correctly identified before and after photos for 100 Hz treatment is not significantly lower than the 50 Hz treatment assessment.
Time frame: At 12 week follow up visit
Assessing Participant Satisfaction
Improvement in cellulite as measured by the percentage of participants who agree or strongly agree that the final photograph of the treatment area as compared to the baseline photograph, appears improved.
Time frame: At the 12 week follow up visit
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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