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Status unknownNCT02287389Updated Nov 10, 2014

Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

An interventional study of balloon dilation and cryotherapy in Obstructive Airway Disease, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-11-10.

Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 mitomycin C injection
02

Conditions studied

  • Obstructive Airway Disease
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 160 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • existence of severe organ disfunction
  • allergic to anesthesia drugs
  • refuse to participate the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    balloon dilation

    give the cases balloon dilation as the intervention

    Device: balloon dilation

  • Experimental
    balloon dilation plus cryotherapy

    give the cases balloon dilation plus cryotherapy as the intervention

    Device: balloon dilation · Procedure: cryotherapy

  • Experimental
    BD plus spiculiform electrosurgery

    give the cases balloon dilation plus spiculiform electrosurgery as the intervention

    Device: balloon dilation · Procedure: spiculiform electrosurgery

  • Experimental
    BD plus mitomycin C

    give the cases Balloon dilation plus mitomycin C as the intervention

    Device: balloon dilation · Drug: mitomycin C

Interventions

  • Deviceballoon dilation
  • Procedurecryotherapy
  • Procedurespiculiform electrosurgery
  • Drugmitomycin C
06

What researchers measure

Primary outcomes

  1. percentage of the cases that got Ⅰand Ⅱlevel remission

    Time frame: 3 months

Secondary outcomes

  1. the values of dispnea index

    Time frame: 3 months

  2. Karnofsky Physical scales

    Time frame: 3 months

Other outcomes

  1. adverse event during the treatment

    Time frame: 3 months

07

Study locations

1 site
  • Tangdu Hospital
    Xi'an, Shaanxi 710038, China
    • Deguang Mu, Ph.D · Contact · deguang@fmmu.edu.cn · 86-29-84777825
    • Deguang Mu, Ph.D · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02287389
Lead sponsor
Tang-Du Hospital
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
First posted
Nov 10, 2014
Start date
Dec 2014
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Nov 10, 2014

Study contacts

Deguang Mu, PhD
Contact
deguang@fmmu.edu.cn
86-29-84777825
Yandong Nan, MD
Contact
nanyandong2008@163.com
86-29-84717533
Faguang Jin, PhD
principal investigator · Tang-Du Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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