Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators
|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: NCT01377740|
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fat Reduction in the Abdomen||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:||Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Device: The Zeltiq System
- Independent imaging review [ Time Frame: 16 weeks ]The primary effectiveness endpoint is the percent of reviews by the reviewers which either identify no clinically significant difference in fat reduction between the two sides of the abdomen, or identify greater fat reduction on the side of the abdomen treated with the CoolFlex applicator at 8 weeks post-treatment. It is expected that the percentage of reviews identifying no clinically significant difference between the two sides of the abdomen or identifying greater fat reduction on the side of the abdomen treated with the CoolFlex applicator at 8 weeks post-treatment will be at least 75%.
- Overall reduction [ Time Frame: 16 weeks ]Overall reduction in the fat layer thickness on each side of the abdomen, as demonstrated by comparison of pre-treatment and 8- and 16-week post-treatment ultrasound measurements, for all evaluable subjects (i.e., adequate ultrasound imaging data sets).
- Subject satisfaction [ Time Frame: 16 weeks ]Subject satisfaction with the Zeltiq procedure as determined by the results of a subject satisfaction questionnaire at the 8- and 16-week follow-up visits.
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): NCT01377740
|Canada, British Columbia|
|Arbutus Laser Centre|
|Vancouver, British Columbia, Canada, V6J IZ6|
|Institute of Cosmetic and Laser Surgery|
|Oakville, Ontario, Canada, L6J 7W5|
|Principal Investigator:||Gerald Boey, MD||Arbutus Laser Centre|