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This study is being done to compare two commonly available types of body contouring, VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one procedure is preferred by patients and/or surgeons over the other. Participants will have VAL on one side of their body and SAL on the opposite side.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAL | Active Comparator | Each patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side) |
|
| VAL | Active Comparator | Each patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suction-assisted Lipoplasty | Device | Standard Suction-assisted lipoplasty will be performed on one side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back |
| Measure | Description | Time Frame |
|---|---|---|
| Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the difference in patients' post-operative pain level between the SAL side and the VAL side | 6 months | |
| To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Onelio Garcia, MD, F.A.C.S | Plastic Surgery Center of South Florida | Principal Investigator |
| Michael Nagy, MD, F.A.C.S | Personal Enhancement Center | Principal Investigator |
| Paul F Vanek, MD, F.A.C.S. | Lake Hospital Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgery Center of South Florida | Miami | Florida | 33146 | United States | ||
| Personal Enhancement Center |
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| Label | URL |
|---|---|
| Sound Surgical Technology - technique description | View source |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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|
| VASER-assisted lipoplasty | Device | VASER-assisted lipoplasty will be performed on the opposite side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back |
|
|
| To assess the difference in post-operative patient preference between the SAL side and the VAL side | 6 months |
| To assess the difference in post-operative ecchymosis between the SAL side and the VAL side | 6 months |
| To assess the difference in post-operative skin retraction between the SAL side and the VAL side | 6 months |
| To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side | 1 day |
| To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure | 6 months |
| To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure. | 6 months |
| Toms River |
| New Jersey |
| 08753 |
| United States |
| Paul F. Vanek, M.D., F.A.C.S. | Mentor | Ohio | 44060 | United States |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |