Early Phase 1
N=4
Application of the Apsara Thermal Wand System
Tightening of Skin Laxity
Bottom Line
View on ClinicalTrials.gov: NCT00662389 ↗Enrolled (actual)
4
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Serious Adverse Events — 0 Number of Serious Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Apsara Thermal Wand System (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Apsara Medical Corporation
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events |
— | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00662389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.