UltraShape Power in Combination With U-sculpt-n Transducer
|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: NCT02956720|
Recruitment Status : Unknown
Verified July 2017 by Ronen Glesinger, Syneron Candela.
Recruitment status was: Recruiting
First Posted : November 7, 2016
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Circumference Reduction||Device: UltraShape Power||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective, single arm|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||October 2018|
|Experimental: single arm||
Device: UltraShape Power
non-invasive body contouring procedure
- Outer thigh circumference reduction [ Time Frame: up to 24 week ]To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.
- Treatment-related adverse events [ Time Frame: up to 24 week ]The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.
- Subject satisfaction questionnaire [ Time Frame: up to 24 week ]The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale
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): NCT02956720
|Contact: Ketty Shkolnik, Ph.D.||+firstname.lastname@example.org|
|Ramat Gan, Israel|
|Contact: Ronen Glesinger, Dr|