We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

VASER Treatment of Axillary Hyperhidrosis/Bromidrosis (VASER AxHH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735293
First Posted: August 14, 2008
Last Update Posted: September 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sound Surgical Technologies, LLC.
Information provided by:
Commons Aesthetic Plastic Surgery
  Purpose
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

Condition Intervention Phase
Axillary Hyperhidrosis Device: VASER Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis

Further study details as provided by Commons Aesthetic Plastic Surgery:

Primary Outcome 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 Outcome 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 ]

Enrollment: 13
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis
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.
Other Name: Sound VASER System

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735293


Locations
United States, California
Commons Aesthetic Plastic Surgery
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Commons Aesthetic Plastic Surgery
Sound Surgical Technologies, LLC.
  More Information

Additional Information:
Responsible Party: George W. Commons, M.D., Commons Aesthetic Plastic Surgery
ClinicalTrials.gov Identifier: NCT00735293     History of Changes
Other Study ID Numbers: VASER AxHH
First Submitted: August 12, 2008
First Posted: August 14, 2008
Last Update Posted: September 19, 2008
Last Verified: September 2008

Keywords provided by Commons Aesthetic Plastic Surgery:
hyperhidrosis
bromidrosis
bromhidrosis
osmidrosis
hircismus
excessive
underarm
sweat
perspiration
Body Odor

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases