Tightening of Skin Laxity Clinical Trial
Official title:
TP-1013 Pilot 1: Application of the Apsara Thermal Wand System
| Verified date | July 2009 |
| Source | Apsara Medical Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this feasibility study is to gain an initial assessment of the acute safety and performance of the Apsara Thermal Wand System in human facial tissue.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 40 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Nonsmoker - Glogau class 1-3 - Previously chosen to undergo facelift Exclusion Criteria: - Pregnant, nursing - Implanted electro-mechanical device - Allergy to anesthesia or device metals - Collagen vascular disease - History of keloid or hypertrophic scar formation - Uncontrolled diabetes - Long term steroid or other immunologic inhibitor use - Previous treatment to target area - Does not consent to study - Does not consent to photography or histological evaluation |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Bryant A. Toth, MD, FACS | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Apsara Medical Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serious Adverse Events | Immediate | Yes |