Multi-Center Pilot Study of Cutera truSculpt Device
|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: NCT03782545|
Recruitment Status : Unknown
Verified December 2018 by Cutera Inc..
Recruitment status was: Active, not recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment for Cellulite on the Stomach and Flanks||Device: Cutera truSculpt Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.|
|Masking:||None (Open Label)|
|Masking Description:||This is an open label study.|
|Official Title:||Multi-Center Pilot Study of Cutera truSculpt Device|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||May 31, 2019|
- Device: Cutera truSculpt Device
The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.
- Incidence and severity of adverse device effects. [ Time Frame: up to 12 week follow up ]Incidence and severity of adverse device effects.
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): NCT03782545
|United States, California|
|Laser and Skin Surgery Center of Northern California|
|Sacramento, California, United States, 95816|
|United States, Illinois|
|Glencoe, Illinois, United States, 60022|
|United States, New York|
|Union Square Dermatology|
|New York, New York, United States, 10003|