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Silk Medical Aesthetics' Inc. device, SMA-001, is currently under development as a dermal filler to fill wrinkles and folds. This study is designed to collect short-term visual, photographic, and histological and safety data on small aliquots of the product as part of device development. It is an open label study involving up to three investigational sites and a maximum enrollment of 10 subjects. Juvéderm Ultra Plus XC, an FDA-approved dermal filler will serve as a control device. Briefly, the investigational product and the control device will be injected into the abdomen of patients intending to undergo abdominoplasty at a later date. The patients will be followed for 30 days post injection through visual observation. At 30 days post injection, the injected gel and associated tissue will be removed via biopsy during the abdominoplasty surgery and histology slides created for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Abdominal Injections | Experimental | Ten injections per patient: 7 of SMA-001 and 3 of control device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMA-001 | Device | Intra-dermal injection of SMA-001 and control device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological performance | Four week histology data | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety of the device through Adverse Event tracking | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skincare Physicians, Inc | Chestnut Hill | Massachusetts | 02467 | United States | ||
| Gryskiewicz Twin Cities Cosmetic Surgery |
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| Burnsville |
| Minnesota |
| 55337 |
| United States |
| Jewell Plastic Surgery | Eugene | Oregon | 97401 | United States |