VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

Overview

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

Full Title of Study: “The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: Treatment
    • There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • To assess patient’s post-operative pain level following VASER using patient self report assessments.
    • Time Frame: 2 months
  • To assess patients healing time following VASER treatment of axillary hyperhidrosis
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Commons Aesthetic Plastic Surgery
  • Collaborator
    • Sound Surgical Technologies, LLC.
  • Provider of Information About this Clinical Study
    • George W. Commons, M.D., Commons Aesthetic Plastic Surgery

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