Axillary HyperhidrosisPhase 4VASER AxHHNCT00735293
VASER Treatment of Axillary Hyperhidrosis/Bromidrosis
A Phase 4 study testing VASER in people with Axillary Hyperhidrosis, run by Commons Aesthetic Plastic Surgery at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- VASER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Commons Aesthetic Plastic Surgery
Palo Alto, California, 94306
About this study
Official title: The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis
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
Read the 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.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- VASER
- Keywords
- hyperhidrosis, bromidrosis, bromhidrosis, osmidrosis, hircismus, excessive, underarm, sweat, perspiration, Body Odor
- Medical subject headings
- Hyperhidrosis, Body Odor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASERDevice
Also called Sound VASER System
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis Receives: Device: VASER |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments
Measured: 6 months
To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment
Measured: 6 months
Secondary outcomes (3)
To assess patient's post-operative pain level following VASER using patient self report assessments.
Measured: 2 months
To assess patients healing time following VASER treatment of axillary hyperhidrosis
Measured: 6 months
To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Commons Aesthetic Plastic Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Sound Surgical Technologies, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735293
- Sponsor's protocol ID
- VASER AxHH
- Acronym
- VASER AxHH
- Status last verified
- Sep 2008
- First submitted
- 12 Aug 2008
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis
- ClinicalTrials.gov ID
- NCT00735293
- Acronym / sponsor ID
- VASER AxHH / VASER AxHH
- Conditions
- Axillary Hyperhidrosis
- Keywords
- hyperhidrosis, bromidrosis, bromhidrosis, osmidrosis, hircismus, excessive, underarm, sweat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Commons Aesthetic Plastic SurgeryUniversity, hospital or other
- Collaborators
- Sound Surgical Technologies, LLC.
- Study start
- Apr 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: VASERThere is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VASERAlso: Sound VASER SystemA 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. | Device | Treatment |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2008.
- Sound VASER SystemLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VASER in people with Axillary Hyperhidrosis, run by Commons Aesthetic Plastic Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2008.