VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

NCT ID: NCT00735293

Last Updated: 2008-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-08-31

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.

Conditions

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Axillary Hyperhidrosis

Keywords

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hyperhidrosis bromidrosis bromhidrosis osmidrosis hircismus excessive underarm sweat perspiration Body Odor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type OTHER

VASER

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Sound VASER System

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sound Surgical Technologies, LLC.

INDUSTRY

Sponsor Role collaborator

Commons Aesthetic Plastic Surgery

OTHER

Sponsor Role lead

Responsible Party

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Commons Aesthetic Plastic Surgery

Locations

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Commons Aesthetic Plastic Surgery

Palo Alto, California, United States

Site Status

Countries

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United States

Related Links

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http://vaser.com

Sound VASER System

Other Identifiers

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VASER AxHH

Identifier Type: -

Identifier Source: org_study_id