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VASER Treatment of Axillary Hyperhidrosis/Bromidrosis (VASER AxHH)

Primary Purpose

Axillary Hyperhidrosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VASER
Sponsored by
Commons Aesthetic Plastic Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axillary Hyperhidrosis focused on measuring hyperhidrosis, bromidrosis, bromhidrosis, osmidrosis, hircismus, excessive, underarm, sweat, perspiration, Body Odor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Commons Aesthetic Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments
To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2008
Last Updated
September 17, 2008
Sponsor
Commons Aesthetic Plastic Surgery
Collaborators
Sound Surgical Technologies, LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00735293
Brief Title
VASER Treatment of Axillary Hyperhidrosis/Bromidrosis
Acronym
VASER AxHH
Official Title
The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Commons Aesthetic Plastic Surgery
Collaborators
Sound Surgical Technologies, LLC.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Hyperhidrosis
Keywords
hyperhidrosis, bromidrosis, bromhidrosis, osmidrosis, hircismus, excessive, underarm, sweat, perspiration, Body Odor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis
Intervention Type
Device
Intervention Name(s)
VASER
Other Intervention Name(s)
Sound VASER System
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments
Time Frame
6 months
Title
To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To assess patient's post-operative pain level following VASER using patient self report assessments.
Time Frame
2 months
Title
To assess patients healing time following VASER treatment of axillary hyperhidrosis
Time Frame
6 months
Title
To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Commons Aesthetic Plastic Surgery
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States

12. IPD Sharing Statement

Links:
URL
http://vaser.com
Description
Sound VASER System

Learn more about this trial

VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

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