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The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.
At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive Cryolipolysis Device | Active Comparator | The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart. |
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| High Intensity Focused Ultrasound Device | Active Comparator | The LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Focused Ultrasound Device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12 | The primary outcome was a blinded rating of the treatment area (Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 12). | 1 hour at baseline and week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| Noninvasive Cryolipolysis Device |
| Device |
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