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This is an open label multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFugeâ„¢ system in facial aesthetics and contouring. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFugeâ„¢ system followed by an injection of autologous microsized adipose tissue in the treatment sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SyntrFuge System | Experimental | Adipose tissue microsized via the SyntrFuge System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyntrFuge System | Device | Microsized Adipose Tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| FaceQ Satisfaction surveys | Change from baseline in FACE-Q Satisfaction with questionnaire score for the treated regions | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement Scale (GAIS) | Change in facial regions characteristics as measured by the Global Aesthetic Improvement Scale (GAIS) form from baseline | 6 months |
| Investigator's Satisfaction Scale |
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Inclusion Criteria:
1.5.2 Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach Site 1 | Newport | California | 92660 | United States | ||
| Newport Beach Site 2 |
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Change in facial regions characteristics as measured by the Investigator's Satisfaction Scale form from baseline
| 6 months |
| Newport Beach |
| California |
| 92660 |
| United States |