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Application of the Apsara Thermal Wand System

NCT ID: NCT00662389

Last Updated: 2009-08-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tightening of Skin Laxity

Keywords

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skin laxity, wrinkles, rhytids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Apsara Thermal Wand System

Intervention Type DEVICE

Single radiofrequency cycle to dermal tissue

Interventions

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Apsara Thermal Wand System

Single radiofrequency cycle to dermal tissue

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Apsara Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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VP, Clinical/Regulatory/Quality

Locations

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Bryant A. Toth, MD, FACS

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NEIRB08-090

Identifier Type: -

Identifier Source: org_study_id