Application of the Apsara Thermal Wand System

July 22, 2009 updated by: Apsara Medical Corporation

TP-1013 Pilot 1: Application of the Apsara Thermal Wand System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Bryant A. Toth, MD, FACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Device: Apsara Thermal Wand System
Single radiofrequency cycle to dermal tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: Immediate
Number of Serious Adverse Events
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apsara Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

July 22, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEIRB08-090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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