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This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.
The purpose of this study is to evaluate the safety and feasibility of a new product under development for non-invasive fat reduction. The new product delivers controlled cooling via a conformable surface applicator, rather than the existing vacuum applicator. A range of treatment parameters will be investigated. At the investigator's discretion, each treatment area may receive up to 3 treatments, spaced 2 - 8 weeks apart. The subjects will return for follow-up at 2 months and 4 months after final treatment. Therefore, the entire study period may last up to 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat Reduction | No Intervention |
|
| 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 |
|---|---|---|
| Efficacy Assessment through Ultrasound Measurements | The primary endpoint will be analyzed by percent reduction in fat layer thickness, as measured by ultrasound. • Safety endpoint: incidence of device- or procedure-related adverse events. Acceptance criteria - zero incidences of UADEs. | 16 weeks post final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Measured by Photo Review and Subject Satisfaction Questionnaire |
| 16 weeks post final treatment |
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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 |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |