Application of the Apsara Thermal Wand System

This study is ongoing, but not recruiting participants.

First Received: April 17, 2008 Last Updated: June 6, 2008 History of Changes

Sponsored by:	Apsara Medical Corporation
Information provided by:	Apsara Medical Corporation
ClinicalTrials.gov Identifier:	NCT00662389

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety Study
Official Title:	TP-1013 Pilot 1: Application of the Apsara Thermal Wand System

Further study details as provided by Apsara Medical Corporation:

Primary Outcome Measures:

Serious adverse events [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Estimated Enrollment:	5
Study Start Date:	April 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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:	VP, Clinical/Regulatory/Quality ( Kim Tompkins )
Study ID Numbers:	NEIRB08-090
Study First Received:	April 17, 2008
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00662389 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Apsara Medical Corporation:

skin laxity, wrinkles, rhytids

Study placed in the following topic categories:

Genetic Diseases, Inborn
Skin Diseases
Cutis Laxa
Connective Tissue Diseases
Skin Diseases, Genetic

Additional relevant MeSH terms:

Skin Diseases
Genetic Diseases, Inborn
Cutis Laxa
Connective Tissue Diseases
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on May 07, 2009