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This study is being performed to reduce unwanted fat in the arm using a new applicator for the Zeltiq System.
The primary objective of the study is to evaluate the safety and performance of the CoolFlex applicator in the flat configuration for reduction of fat in the upper arms.
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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 | Performance will be evaluated by changes in the contour as established by blinded photographic review of a series of pre- and 16-week post-treatment images for each subject. | 16 weeks |
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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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| Oakville |
| Ontario |
| L6J 7W5 |
| Canada |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |