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Application of the Apsara Thermal Wand System

This study has been completed.
Information provided by:
Apsara Medical Corporation Identifier:
First received: April 17, 2008
Last updated: July 22, 2009
Last verified: July 2009
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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00662389

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 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

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 processed this record on September 21, 2017