Palmar HyperhidrosisNCT03840655
Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis
An observational study of Palmar Hyperhidrosis, run by Peking University People's Hospital at 1 site in China.
Trial summary
T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Palmar Hyperhidrosis
- What is being tested?
- Near-Infrared Imaging Thoracoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2017to 1 Sep 2018
- Phase
- Observational
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients suffering from primary palmar hyperhidrosis
Who may be able to join
- Diagnosed with primary palmar hyperhydrosis.
- Accept surgical treatment and signed informed consent.
Who cannot join
- Liver dysfunction.
- Allergic to indocyanine green.
- Can't tolerate thoracoscopic surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People'S Hospital
Beijing, Beijing Municipality, +86-010
About this study
T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The team from thoracic department of Peking University People's Hospital discovered that the sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct a more precise operation and compare the efficiency of the novel and traditional methods.
- Conditions
- Palmar Hyperhidrosis
- Being tested
- Near-Infrared Imaging Thoracoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Imaging ThoracoscopyProcedure or surgery
Sympathicotomy performed by near-infrared imaging thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| palmar hyperhidrosis | VATS R4 Sympathicotomy performed on all patients. Fluorescent thoracoscopy was used to identify the shifting mode of sympathetic ganglions. Receives: Procedure: Near-Infrared Imaging Thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical variation of the sympathetic ganglions
Record the spatial relationship between sympathetic ganglions and ribs, for example: T3/R4 represents the T3 sympathetic ganglion is located on the 4th rib.
Measured: during surgery
Secondary outcomes (2)
Improvement of palmar sweating
Use questionnaire including 3 descriptive names of scale ( over dry, comfortable and wet) to record the surgical effect on palmar sweating.
Measured: 1 month after surgery
Degree of compensatory hyperhidrosis
Use questionnaire including 4 descriptive names of scale ( none, mild, moderate and severe) to record the side effect (compensatory hyperhidrosis) of this surgery.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start16 Nov 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840655
- Sponsor's protocol ID
- 2017PHB101-01
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis
- ClinicalTrials.gov ID
- NCT03840655
- Acronym / sponsor ID
- 2017PHB101-01
- Conditions
- Palmar Hyperhidrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- 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.
T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The team from thoracic department of Peking University People's Hospital discovered that the sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct a more precise operation and compare the efficiency of the novel and traditional methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| palmar hyperhidrosis | – | Procedure: Near-Infrared Imaging ThoracoscopyVATS R4 Sympathicotomy performed on all patients. Fluorescent thoracoscopy was used to identify the shifting mode of sympathetic ganglions. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients suffering from primary palmar hyperhidrosis
Key inclusion criteria (2 listed)
- Diagnosed with primary palmar hyperhydrosis.
- Accept surgical treatment and signed informed consent.
Key exclusion criteria (3 listed)
- Liver dysfunction.
- Allergic to indocyanine green.
- Can't tolerate thoracoscopic 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 |
|---|---|---|
| Near-Infrared Imaging ThoracoscopySympathicotomy performed by near-infrared imaging thoracoscopy | Procedure or surgery | palmar hyperhidrosis |
Primary outcome
Anatomical variation of the sympathetic ganglions
Time frame: during surgery
Record the spatial relationship between sympathetic ganglions and ribs, for example: T3/R4 represents the T3 sympathetic ganglion is located on the 4th rib.
2 secondary outcomes
Improvement of palmar sweating
Time frame: 1 month after surgery
Degree of compensatory hyperhidrosis
Time frame: 1 month after surgery
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 15 Feb 2019.
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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.
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?
An observational study of Palmar Hyperhidrosis, run by Peking University People's 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 2 inclusion and 3 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 15 Feb 2019. 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?
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?
Anatomical variation of the sympathetic ganglions (time frame: during surgery). 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 15 Feb 2019.