Treatment of Abdomen Study (CMI)
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|ClinicalTrials.gov Identifier: NCT02787850|
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The ZELTIQ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the abdomen with a new applicator design.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
- Blinded independent review of photographs to assess change in visible abdomen fat between baseline (pre-treatment) and 12 weeks post treatment. [ Time Frame: 12 weeks post treatment ]The primary efficacy endpoint of the study will be determined by correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success will be defined as at least 70% correct identification of the baseline (pre-treatment) photographs.
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): NCT02787850
|United States, Florida|
|Bowes Dermatology Group|
|Miami, Florida, United States, 33133|
|Principal Investigator:||Leyda Bowes, MD||Bowes Dermatology Group|