Application of the Apsara Thermal Wand System
Early Phase 1
Completed
- Conditions
- Tightening of Skin Laxity
- Interventions
- Device: Apsara Thermal Wand System
- Registration Number
- NCT00662389
- Lead Sponsor
- Apsara Medical Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Apsara Thermal Wand System -
- Primary Outcome Measures
Name Time Method Serious Adverse Events Immediate Number of Serious Adverse Events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bryant A. Toth, MD, FACS
🇺🇸San Francisco, California, United States