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Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltraShape Power | Device | non-invasive body contouring procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Outer thigh circumference reduction | To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side. | up to 24 week |
| Treatment-related adverse events | The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer. | up to 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction questionnaire | The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale | up to 24 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ketty Shkolnik, Ph.D. | Contact | +972-73-2442268 | kettys@syneron-candela.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beit Noah | Recruiting | Ramat Gan | Israel |
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prospective, single arm
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