VASER Treatment of Axillary Hyperhidrosis/Bromidrosis (VASER AxHH)

September 17, 2008 updated by: Commons Aesthetic Plastic Surgery

The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis

Patients with excessive underarm odor and sweating and/or odor are treated with the VASER system to determine the VASER's effectiveness in reducing underarm sweat and odor

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with excessive underarm sweat and/or odor are recruited. The effect that excessive underarm sweat and/or odor has on their lifestyle is evaluated. They are surgically treated with the VASER system and followed up for 6 months to evaluate side effects, adverse events and effectiveness. Additional lifestyle evaluations are completed for comparison to pre-surgery answers.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

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
      • Palo Alto, California, United States, 94306
        • Commons Aesthetic Plastic Surgery

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Willing and able to appear for all scheduled, post-operative visits
  • Have axillary hyperhidrosis/bromidrosis that does not respond to conventional, non-invasive treatment

Exclusion Criteria:

  • under the age of 18
  • have undergone a prior surgical intervention for treatment of axillary hyperhidrosis (e.g.) Skoog procedure, ETS)
  • have been treated with a systemic or topical agent for axillary hyperhidrosis in the past 30 days
  • are deemed inappropriate candidates for surgery due to medical or mental health reasons
  • are currently being treated with investigational agents or have participated in an investigational study within 60 days prior to surgery
  • elect not to participate in the study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment
There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis
Device: VASER
A small incision will be made in the underarm. A VASER probe will be inserted under the skin to break apart fat and sweat glands under the skin. A small hollow tube will be used to draw out the broken-down skin and the incision will be closed with a stitch.
Other Names:
  • Sound VASER System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments
Time Frame: 6 months
6 months
To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess patient's post-operative pain level following VASER using patient self report assessments.
Time Frame: 2 months
2 months
To assess patients healing time following VASER treatment of axillary hyperhidrosis
Time Frame: 6 months
6 months
To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Commons Aesthetic Plastic Surgery

Collaborators

Sound Surgical Technologies, LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 17, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VASER AxHH

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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