CoolSculpting and EMS for the Abdomen (ECA)
|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: NCT03738891|
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : August 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The ZELTIQ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring|
|Actual Study Start Date :||November 7, 2018|
|Actual Primary Completion Date :||September 9, 2019|
|Actual Study Completion Date :||September 9, 2019|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the abdomen.
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 1 day visit ]Measurement of device- or procedure-related adverse events.
- Effectiveness endpoint gauged by photographs [ Time Frame: Final post treatment 1 day visit ]Comparison of pre-treatment- and 12-week post-final treatment photographs to assess visible changes in the abdomen.
- 3-D imaging [ Time Frame: Final post treatment 1 day visit ]Reduction in abdominal circumference as measured by 3-Dimensional imaging.
- Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Final post treatment 1 day visit ]Subject- graded GAIS at 12-week post-final treatment follow-up.
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): NCT03738891
|United States, California|
|Marina Plastic Surgery|
|Marina Del Rey, California, United States, 90292|
|Innovation Research Center|
|Pleasanton, California, United States, 94588|
|Laser & Skin Surgery Center of Northern California|
|Sacramento, California, United States, 95816|
|United States, North Carolina|
|Aesthetic Solutions, P.A.|
|Chapel Hill, North Carolina, United States, 27517|
|Study Director:||Kerrie Jiang, NP||Zeltiq Aesthetics|