CoolSculpting the Flanks (CSI)
|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: NCT03304925|
Recruitment Status : Active, not recruiting
First Posted : October 9, 2017
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The ZELTIQ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CoolSculpting the Flanks|
|Actual Study Start Date :||October 25, 2017|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
- Safety endpoint in relation to adverse events [ Time Frame: Final post treatment visit ]Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
- Effectiveness endpoint gauged by reduction in fat layer thickness [ Time Frame: Final post-treatment visit ]Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
- Subject survey [ Time Frame: Final post-treatment visit ]Subject survey as assessed by questionnaire administered at the final post-treatment visit.
- Photo review [ Time Frame: Final post-treatment visit ]Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
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): NCT03304925
|United States, California|
|Innovation Research Center|
|Pleasanton, California, United States, 94588|
|Laser & Skin Surgery Center of Northern California|
|Sacramento, California, United States, 95816|
|United States, Massachusetts|
|SkinCare Physicians of Chestnut Hill|
|Chestnut Hill, Massachusetts, United States, 02467|
|United States, Minnesota|
|Zel Skin & Laser Specialist|
|Edina, Minnesota, United States, 55424|
|United States, New York|
|Laser & Skin Surgery Center of New York|
|New York, New York, United States, 10016|
|United States, Tennessee|
|Brian S. Biesman, MD|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|EpiCenter Skincare and Laser Center|
|Dallas, Texas, United States, 95231|
|Study Director:||Kerrie Jiang, NP||Zeltiq Aesthetics|