This study is being performed to reduce unwanted abdominal fat using two different applicators for the Zeltiq System.
The primary objective of the study is to evaluate the performance of the CoolFlex applicator compared to the performance of the eZ App 6.3 applicator in the treatment of abdominal fat in terms of its ability to achieve a discernable change to the contour of the treated area.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Arbutus Laser Centre
Vancouver, British Columbia, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
Independent imaging review
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%.
Time frame: 16 weeks
Overall reduction
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).
Time frame: 16 weeks
Subject satisfaction
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.
Time frame: 16 weeks
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