NCT00735293

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

1.3 years

First QC Date

August 12, 2008

Last Update Submit

September 17, 2008

Conditions

Axillary Hyperhidrosis

Keywords

hyperhidrosisbromidrosisbromhidrosisosmidrosishircismusexcessiveunderarmsweatperspirationBody Odor

Outcome Measures

Primary Outcomes (2)

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

    6 months

  • To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment

    6 months

Secondary Outcomes (3)

  • To assess patient's post-operative pain level following VASER using patient self report assessments.

    2 months

  • To assess patients healing time following VASER treatment of axillary hyperhidrosis

    6 months

  • To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER

    6 months

Study Arms (1)

Treatment

OTHER

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

Device: VASER

Interventions

VASERDEVICE

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.

Also known as: Sound VASER System
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Commons Aesthetic Plastic Surgery

Palo Alto, California, 94306, United States

Location

Related Links

MeSH Terms

Conditions

HyperhidrosisBody Odor

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 14, 2008

Study Start

April 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

US(1)