An interventional study of Soliton's Rapid Acoustic Pulse (RAP) in Cellulite, sponsored by Soliton. Completed at 4 sites in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Soliton · Not applicable, Interventional, and Treatment
To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.
Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.
Exclusion Criteria:
Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment.
Device: Soliton's Rapid Acoustic Pulse (RAP)
Treatment for the temporary improvement in the appearance of cellulite.
Procedure Safety- All treated participants are free from unexpected adverse events
The primary objective is to demonstrate freedom from unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment.
Time frame: 12 weeks
RAP treatment effectiveness
To demonstrate temporary improvement in the appearance of cellulite as determined by blinded independent physician assessment (IPA) correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs.
Time frame: 12 weeks, 26 weeks and 52 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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Soliton