VASER Treatment of Axillary Hyperhidrosis/Bromidrosis (VASER AxHH)

This study has been completed.
Sponsor:
Collaborator:
Sound Surgical Technologies, LLC.
Information provided by:
Commons Aesthetic Plastic Surgery
ClinicalTrials.gov Identifier:
NCT00735293
First received: August 12, 2008
Last updated: September 17, 2008
Last verified: September 2008
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess patient's post-operative pain level following VASER using patient self report assessments. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To assess patients healing time following VASER treatment of axillary hyperhidrosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: George W. Commons, M.D., Commons Aesthetic Plastic Surgery
ClinicalTrials.gov Identifier: NCT00735293     History of Changes
Other Study ID Numbers: VASER AxHH
Study First Received: August 12, 2008
Last Updated: September 17, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014