Obstructive Airway DiseaseNCT02287389
Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
A study testing balloon dilation, cryotherapy and spiculiform electrosurgery in people with Obstructive Airway Disease, run by Tang-Du Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture. The four techniques are： balloon dilation balloon dilation plus cryotherapy balloon dilation plus spiculiform electrosurgery balloon dilation plus… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Airway Disease
- What is being tested?
- balloon dilation, cryotherapy and spiculiform electrosurgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis
- the degree of stenosis is above 50%
- estimated survival duration is longer than 3 months
- recieved no treatment one month before
- can understand the statement informed consent
- agree to enroll in the study
Who cannot join
- older than 70 years or younger than 18 years
- not fibrotic stenosis
- not central airway stenosis
- existence of lumina collapse or twisting
- severe arrhythmia, myocardial ischemia or hypertensive crisis
- coagulation disorders
Show all 9Show fewer
- existence of severe organ disfunction
- allergic to anesthesia drugs
- refuse to participate the study
Trial locations and contacts
1 site in 1 country.
China1 site
Tangdu Hospital
Xi'an, Shaanxi, 710038
Deguang Mu, Ph.D, 86-29-84777825, deguang@fmmu.edu.cn
Deguang Mu, Ph.D
About this study
Official title: Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture.
The four techniques are：
- balloon dilation
- balloon dilation plus cryotherapy
- balloon dilation plus spiculiform electrosurgery
- balloon dilation plus mitomycin C injection
- Conditions
- Obstructive Airway Disease
- Being tested
- balloon dilation, cryotherapy, spiculiform electrosurgery, mitomycin C
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon dilationDevice
cryotherapyProcedure or surgery
spiculiform electrosurgeryProcedure or surgery
mitomycin CDrug
| Study group | Role | What they receive |
|---|---|---|
| balloon dilation | Experimental | give the cases balloon dilation as the intervention Receives: Device: balloon dilation |
| balloon dilation plus cryotherapy | Experimental | give the cases balloon dilation plus cryotherapy as the intervention Receives: Device: balloon dilation; Procedure: cryotherapy |
| BD plus spiculiform electrosurgery | Experimental | give the cases balloon dilation plus spiculiform electrosurgery as the intervention Receives: Device: balloon dilation; Procedure: spiculiform electrosurgery |
| BD plus mitomycin C | Experimental | give the cases Balloon dilation plus mitomycin C as the intervention Receives: Device: balloon dilation; Drug: mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of the cases that got Ⅰand Ⅱlevel remission
Measured: 3 months
Secondary outcomes (2)
the values of dispnea index
Measured: 3 months
Karnofsky Physical scales
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 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 Obstructive Airway DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Faguang Jin, PhD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287389
- Sponsor's protocol ID
- CAO-NO.201402024-benign
- Other IDs
- NO.201402024
- Status last verified
- Nov 2014
- First submitted
- 26 Oct 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
- ClinicalTrials.gov ID
- NCT02287389
- Acronym / sponsor ID
- CAO-NO.201402024-benign
- Conditions
- Obstructive Airway Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Nov 2014 (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.
The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture.
The four techniques are：
- balloon dilation
- balloon dilation plus cryotherapy
- balloon dilation plus spiculiform electrosurgery
- balloon dilation plus mitomycin C injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| balloon dilation | Experimental | Device: balloon dilationgive the cases balloon dilation as the intervention |
| balloon dilation plus cryotherapy | Experimental | Device: balloon dilation, Procedure: cryotherapygive the cases balloon dilation plus cryotherapy as the intervention |
| BD plus spiculiform electrosurgery | Experimental | Device: balloon dilation, Procedure: spiculiform electrosurgerygive the cases balloon dilation plus spiculiform electrosurgery as the intervention |
| BD plus mitomycin C | Experimental | Device: balloon dilation, Drug: mitomycin Cgive the cases Balloon dilation plus mitomycin C as the intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis
- the degree of stenosis is above 50%
- estimated survival duration is longer than 3 months
- recieved no treatment one month before
- can understand the statement informed consent
Key exclusion criteria (9 listed)
- older than 70 years or younger than 18 years
- not fibrotic stenosis
- not central airway stenosis
- existence of lumina collapse or twisting
- severe arrhythmia, myocardial ischemia or hypertensive crisis
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 |
|---|---|---|
| balloon dilation | Device | BD plus mitomycin C, BD plus spiculiform electrosurgery, balloon dilation, balloon dilation plus cryotherapy |
| cryotherapy | Procedure or surgery | balloon dilation plus cryotherapy |
| spiculiform electrosurgery | Procedure or surgery | BD plus spiculiform electrosurgery |
| mitomycin C | Drug | BD plus mitomycin C |
Primary outcome
percentage of the cases that got Ⅰand Ⅱlevel remission
Time frame: 3 months
2 secondary outcomes
the values of dispnea index
Time frame: 3 months
Karnofsky Physical scales
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
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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.
Faguang Jin, PhD principal investigator
Tang-Du 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 balloon dilation, cryotherapy and spiculiform electrosurgery in people with Obstructive Airway Disease, 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 6 inclusion and 9 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 10 Nov 2014. 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?
Contact Deguang Mu, PhD (86-29-84777825, deguang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of the cases that got Ⅰand Ⅱlevel remission (time frame: 3 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 10 Nov 2014.