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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Zeltiq System | Device | Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 16 weeks |
| Subject satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Boey, MD | Arbutus Laser Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arbutus Laser Centre | Vancouver | British Columbia | V6J IZ6 | Canada | ||
| Institute of Cosmetic and Laser Surgery |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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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. |
| 16 weeks |
| Oakville |
| Ontario |
| L6J 7W5 |
| Canada |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |