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The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
VelaShape is a non-invasive (not breaking the skin) device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until they break apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velashape III device | Active Comparator | Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation |
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| Noninvasive Cryolipolysis Device | Active Comparator | A noninvasive device that reduces fat by freezing fat cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VelaShape III | Device | Subjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt. |
| Measure | Description | Time Frame |
|---|---|---|
| A blinded rating of the treatment area | Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 3 month post treatment time-point. | 3 month post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| A blinded rating of the treatment area | Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 1 week, 1 month and 6 months post treatment time-point. | 1 week, 1 month and 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Improvement and Satisfaction Scores | Subject Improvement and Satisfaction Scores using the Global Aesthetic Improvement (GAI) Scale and Subject Satisfaction Improvement Scale at each follow-up time point post treatment: 1 week, 1 month, 3 month and 6 month follow-up visits. | 1 week, 1 month, 3 month and 6 month post treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shlomit Mann | Syneron Medical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coleman Center for Cosmetic Dermatologic Surgery | Metairie | Louisiana | 70006 | United States |
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| CoolSculpt | Device | Noninvasive Cryolipolysis |
|
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| Investigator Improvement and Satisfaction Scores |
Investigator Improvement and Satisfaction Scores using the Global Aesthetic Improvement (GAI) Scale and Subject Satisfaction Improvement Scale at each follow-up time point post treatment: 1 week, 1 month, 3 month and 6 month follow-up visits. |
| 1 week, 1 month, 3 month and 6 month post treatment |
| Side Effects and Adverse Events | Safety will be evaluated based on the incidence and severity of adverse events caused by the laser treatments | Study duration |