An interventional study of Soliton Rapid Acoustic Pulse (RAP) in Cellulite, sponsored by Soliton. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Soliton · Not applicable, Interventional, and Device feasibility
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
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).
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 10 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.
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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.
Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.
Device: Soliton Rapid Acoustic Pulse (RAP)
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
Also known as: RAP
Incidence of SAEs
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.
Time frame: 18 weeks
Treatment Tolerability
The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is \< 8.0
Time frame: 18 Weeks
Cellulite improvement
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.
Time frame: 18 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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