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Application of the Apsara Thermal Wand System

This study has been completed.
Sponsor:
Information provided by:
Apsara Medical Corporation
ClinicalTrials.gov Identifier:
NCT00662389
First received: April 17, 2008
Last updated: July 22, 2009
Last verified: July 2009
History of Changes
  Purpose

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 Intervention Phase
Tightening of Skin Laxity
 Device: Apsara Thermal Wand System
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TP-1013 Pilot 1: Application of the Apsara Thermal Wand System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Apsara Medical Corporation:

Primary Outcome Measures:
  • Serious Adverse Events [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Apsara Thermal Wand System
Single radiofrequency cycle to dermal tissue

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662389

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

No publications provided

Responsible Party: Kim Tompkins, VP, Clinical/Regulatory/Quality
ClinicalTrials.gov Identifier: NCT00662389     History of Changes
Other Study ID Numbers: NEIRB08-090
Study First Received: April 17, 2008
Results First Received: July 22, 2009
Last Updated: July 22, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013