Sweat Gland DiseasesNCT01539460
A Minimally Invasive Surgery for Axillary Osmidrosis: Combined Liposuction With Subcutaneous Pruning
A study testing minimally invasive surgery in people with Sweat Gland Diseases, run by Tang-Du Hospital at 1 site in China.
Trial summary
Patients with axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in reducing odor is to be determined. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sweat Gland Diseases
- What is being tested?
- minimally invasive surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Dec 2017
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or older
- unpleasant odor from the axillae
- Willing and able to appear for all scheduled, post-operative visits
Who cannot join
- under the age of 18
- have undergone a prior surgical intervention
- inappropriate candidates for surgery due to medical or mental health reasons
- elect not to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Refined Minimally Invasive Procedure for Radical Treatment of Axillary Osmidrosis: Combined Tumescent Liposuction With Subcutaneous Pruning Through a Small Incision
Patients with axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in reducing odor is to be determined.
Read the detailed description
Patients with excessive malodor are recruited. They are surgically treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning and followed up for 6-24 months to evaluate effectiveness sand side effect.
- Conditions
- Sweat Gland Diseases
- Being tested
- minimally invasive surgery
- Keywords
- Axillary osmidrosis, liposuction, minimally invasive surgery
- Medical subject headings
- Sweat Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive surgeryProcedure or surgery
Subcutaneous fat and apocrine sweat glands were removed by suction under tumescent anesthesia,and the remaining tissue and glands, tightly attached to the epidermis-dermis interface, were completely removed with scissors through the initial small incision.
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive surgery | Experimental | There is only one arm to this study. All patients will receive treatment with the minimally invasive surgery for their axillary bromidrosis Receives: Procedure: minimally invasive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments
the satisfaction of patients
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sweat Gland DiseasesStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUEJUN LI, Tang-Du Hospital
- Investigators
- XUEYONG LI, MD, Study director, Department of Plastics and Burns, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539460
- Sponsor's protocol ID
- TDH0369
- Status last verified
- May 2017
- First submitted
- 21 Feb 2012
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Refined Minimally Invasive Procedure for Radical Treatment of Axillary Osmidrosis: Combined Tumescent Liposuction With Subcutaneous Pruning Through a Small Incision
- ClinicalTrials.gov ID
- NCT01539460
- Acronym / sponsor ID
- TDH0369
- Conditions
- Sweat Gland Diseases
- Keywords
- Axillary osmidrosis, liposuction, minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Feb 2012 (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 axillary osmidrosis are treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning. Effectiveness of this modified method in reducing odor is to be determined.
Detailed description
Patients with excessive malodor are recruited. They are surgically treated with minimally invasive procedure combined tumescent liposuction with Subcutaneous Pruning and followed up for 6-24 months to evaluate effectiveness sand side effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| minimally invasive surgery | Experimental | Procedure: minimally invasive surgeryThere is only one arm to this study. All patients will receive treatment with the minimally invasive surgery for their axillary bromidrosis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years or older
- unpleasant odor from the axillae
- Willing and able to appear for all scheduled, post-operative visits
Key exclusion criteria (4 listed)
- under the age of 18
- have undergone a prior surgical intervention
- inappropriate candidates for surgery due to medical or mental health reasons
- elect not to participate in the study
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 |
|---|---|---|
| minimally invasive surgerySubcutaneous fat and apocrine sweat glands were removed by suction under tumescent anesthesia,and the remaining tissue and glands, tightly attached to the epidermis-dermis interface, were completely removed with scissors through the initial small incision. | Procedure or surgery | minimally invasive surgery |
Primary outcome
To assess the effectiveness of the refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments
Time frame: up to 24 months
the satisfaction of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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.
XUEYONG LI, MD study director
Department of Plastics and Burns, Tangdu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive surgery in people with Sweat Gland Diseases, run by Tang-Du Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 12 May 2017. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
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 refined minimally invasive procedure for radical treatment of axillary osmidrosis using patient self-report assessments (time frame: up to 24 months). 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 12 May 2017.