VASER Treatment of Axillary Hyperhidrosis/Bromidrosis

Axillary Hyperhidrosis Clinical Trial

— VASER AxHH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735293
• Other study ID #: VASER AxHH
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2008
• Last updated: September 17, 2008
• Start date: April 2007
• Est. completion date: August 2008

Study information

• Verified date: September 2008
• Source: Commons Aesthetic Plastic Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Axillary Hyperhidrosis
• Hyperhidrosis

Intervention

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.

Locations

Country	Name	City	State
United States	Commons Aesthetic Plastic Surgery	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Commons Aesthetic Plastic Surgery	Sound Surgical Technologies, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments		6 months	No
Primary	To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment		6 months	No
Secondary	To assess patient's post-operative pain level following VASER using patient self report assessments.		2 months	No
Secondary	To assess patients healing time following VASER treatment of axillary hyperhidrosis		6 months	No
Secondary	To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER		6 months	No

External Links

•   Sound VASER System