Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04065711|
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : September 22, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Cellulite||Device: Soliton's Rapid Acoustic Pulse (RAP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite|
|Actual Study Start Date :||July 20, 2019|
|Actual Primary Completion Date :||July 20, 2021|
|Actual Study Completion Date :||August 26, 2021|
Experimental: RAP Treatment
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 [ Time Frame: 12 weeks ]
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.
- RAP treatment effectiveness [ Time Frame: 12 weeks, 26 weeks and 52 weeks ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||This study is specific to females ages 18-50 years.|
|Accepts Healthy Volunteers:||Yes|
- Female ages 18-50 years
- Seeking treatment of cellulite in the thigh and/or buttock areas
- Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
- Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
- Stable weight nominally +/- 5% for at least the past 6 months.
- 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.
- Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment.
- Participant is willing to participate in study and adhere to follow-up schedule
- Participant is able to read and comprehend English
- Participant has completed the Informed Consent Form
- 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.
- Has atrophic scars, or has a history of atrophic scars or keloids.
- Tattoo or former tattoo at or near treatment area.
- 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.
- Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.).
- History of coagulopathy(ies) and/or on anticoagulant medication.
- Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Current smoker.
- Any surgical procedure in the prior 3 months, or planned during the duration of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065711
|United States, Arizona|
|Clear Dermatology and Aesthetics Center Investigate MD|
|Scottsdale, Arizona, United States, 85255|
|United States, Illinois|
|Chicago Cosmetic Surgery & Dermatology|
|Chicago, Illinois, United States, 60654|
|United States, Maryland|
|Capital Laser and Skin Care|
|Chevy Chase, Maryland, United States, 20815|
|United States, Massachusetts|
|Chestnut Hill, Massachusetts, United States, 02467|
|Study Director:||Christopher Capelli, MD||Soliton, Inc.|
|Other Study ID Numbers:||
|First Posted:||August 22, 2019 Key Record Dates|
|Last Update Posted:||September 22, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|