Back to resultsApplication of the Apsara Thermal Wand System
Primary Purpose
Tightening of Skin Laxity
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Apsara Thermal Wand System
Sponsored by
About this trial
This is an interventional treatment trial for Tightening of Skin Laxity focused on measuring skin laxity, wrinkles, rhytids
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
Sites / Locations
- Bryant A. Toth, MD, FACS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Serious Adverse Events
Number of Serious Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT00662389
First Posted
April 17, 2008
Last Updated
July 22, 2009
Sponsor
Apsara Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00662389
Brief Title
Application of the Apsara Thermal Wand System
Official Title
TP-1013 Pilot 1: Application of the Apsara Thermal Wand System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Apsara Medical Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tightening of Skin Laxity
Keywords
skin laxity, wrinkles, rhytids
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Apsara Thermal Wand System
Intervention Description
Single radiofrequency cycle to dermal tissue
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
Number of Serious Adverse Events
Time Frame
Immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Bryant A. Toth, MD, FACS
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Application of the Apsara Thermal Wand System
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