Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
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|ClinicalTrials.gov Identifier: NCT03981198|
Recruitment Status : Active, not recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cellulite||Device: Soliton Rapid Acoustic Pulse (RAP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group|
|Masking:||None (Open Label)|
|Official Title:||Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||August 5, 2019|
|Estimated Study Completion Date :||August 5, 2019|
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.
Other Name: RAP
- Safety [ Time Frame: 18 weeks ]Evaluate for adverse events attributable to the RAP device.
- Efficacy [ Time Frame: 18 ]To evaluate the reductions of cellulite. Achievement is measured by ≥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.
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): NCT03981198
|United States, Massachusetts|
|Chestnut Hill, Massachusetts, United States, 02467|
|Study Director:||Christopher C Capelli, MD||Soliton|