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Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat Reduction | Experimental | The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The ZELTIQ System | Device | The CoolSculpting machine will be used to perform the treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint in relation to adverse events | Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs | Final post treatment visit |
| Effectiveness endpoint gauged by reduction in fat layer thickness | Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit. | Final post-treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Subject survey | Subject survey as assessed by questionnaire administered at the final post-treatment visit. | Final post-treatment visit |
| Photo review | Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kerrie Jiang, NP | Zeltiq Aesthetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovation Research Center | Pleasanton | California | 94588 | United States | ||
| Laser & Skin Surgery Center of Northern California |
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| Final post-treatment visit |
| Sacramento |
| California |
| 95816 |
| United States |
| SkinCare Physicians of Chestnut Hill | Chestnut Hill | Massachusetts | 02467 | United States |
| Zel Skin & Laser Specialist | Edina | Minnesota | 55424 | United States |
| Laser & Skin Surgery Center of New York | New York | New York | 10016 | United States |
| Brian S. Biesman, MD | Nashville | Tennessee | 37203 | United States |
| EpiCenter Skincare and Laser Center | Dallas | Texas | 95231 | United States |