VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Axillary Hyperhidrosis

Intervention / Treatment
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* Device: VASER


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis | Device: VASER<br>* 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.<br>* Other names: Sound VASER System;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperhidrosis, bromidrosis, bromhidrosis, osmidrosis, hircismus, excessive, underarm, sweat, perspiration, Body Odor