Status:
COMPLETED
Application of the Apsara Thermal Wand System
Lead Sponsor:
Apsara Medical Corporation
Conditions:
Tightening of Skin Laxity
Eligibility:
All Genders
40-65 years
Phase:
EARLY_PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Nonsmoker
- Glogau class 1-3
- Previously chosen to undergo facelift
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00662389
Start Date
April 1 2008
End Date
March 1 2009
Last Update
August 28 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bryant A. Toth, MD, FACS
San Francisco, California, United States, 94115