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 : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cellulite||Device: Soliton's Rapid Acoustic Pulse (RAP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 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 30, 2019|
|Estimated Primary Completion Date :||December 12, 2020|
|Estimated Study Completion Date :||January 30, 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.
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.|