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The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.
The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1064nm laser Treatment Before Abdominoplasty | Experimental | Patient will be treated with 1064nm Laser prior to abdominoplasty |
|
| 940nm Laser Treatment Before Abdominoplasty | Experimental | Patient will be treated with 940nm Laser prior to abdominoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1064nm Laser | Device | Patient will be treated with 1064nm Laser prior to abdominoplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy of Tissue Sample as a Measure of Effectiveness | Biopsy of treated area will be obtained up to 6 months post treatment and will be histologically assessed for changes in adipocytes, collagen and surrounding tissue to determine effectiveness of device | 6 months post treatment |
| Ultrasound Measurement to Evaluate Reduction of Fat | Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat | 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| High Frequency Ultrasound to Measure Skin Elasticity and Thickness | High frequency ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to measure changes in skin elasticity and skin thickness. | 6 months post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patric Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetic Pavilion | Staten Island | New York | 103206 | United States |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 940nm Laser | Device | Patient will be treated with 940nm Laser prior to abdominoplasty |
|