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Application of the Apsara Thermal Wand System

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ClinicalTrials.gov Identifier: NCT00662389
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : August 28, 2009
Last Update Posted : August 28, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Tightening of Skin Laxity Device: Apsara Thermal Wand System Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TP-1013 Pilot 1: Application of the Apsara Thermal Wand System
Study Start Date : April 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Device: Apsara Thermal Wand System
Single radiofrequency cycle to dermal tissue



Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: Immediate ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662389


Locations
United States, California
Bryant A. Toth, MD, FACS
San Francisco, California, United States, 94115
Sponsors and Collaborators
Apsara Medical Corporation

Responsible Party: Kim Tompkins, VP, Clinical/Regulatory/Quality
ClinicalTrials.gov Identifier: NCT00662389     History of Changes
Other Study ID Numbers: NEIRB08-090
First Posted: April 21, 2008    Key Record Dates
Results First Posted: August 28, 2009
Last Update Posted: August 28, 2009
Last Verified: July 2009

Keywords provided by Apsara Medical Corporation:
skin laxity, wrinkles, rhytids

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases