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Application of the Apsara Thermal Wand System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662389
First Posted: April 21, 2008
Last Update Posted: August 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Apsara Medical Corporation
  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 Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Apsara Medical Corporation:

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Kim Tompkins, VP, Clinical/Regulatory/Quality
ClinicalTrials.gov Identifier: NCT00662389     History of Changes
Other Study ID Numbers: NEIRB08-090
First Submitted: April 17, 2008
First Posted: April 21, 2008
Results First Submitted: July 22, 2009
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