UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005322 |
|---|---|
| Receipt number | R000006324 |
| Scientific Title | Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2013/07/29 13:21:49 |
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Basic information
Public title
Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Acronym
Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Scientific Title
Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Scientific Title:Acronym
Assessment of tracheal stenosis using impulse oscillometry (IOS) before and after interventional bronchoscopy
Region
| Japan |
Condition
Condition
cases of tracheal stenosis
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the usefulness in tracheal stenosis before and after interventional procedures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of IOS parameters before and after interventional bronchoscopy
Key secondary outcomes
Comparison between variable and fixed stenosis in IOS parameters
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with tracheal stenosis
Key exclusion criteria
Patients with tracheotomy and a history of pneumonectomy
incapable of performing spirometry and CT
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamichi Mineshita |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki, Japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Handa |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki, Japan
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratory and Infectious Diseases, Department of Internal Medicine, St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学病院 (St. Marianna University School of Medicine Hospital)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
After interventional bronchoscopy, all IOS measurements significantly improved, especially R5 and X20. R5, R5-R20 and X5 changes but not spirometry measurements correlated with changes in MMRC dyspnea scale.
IOS can potentially be used to differentiate fixed from variable obstruction.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
This is an analysis of collected data between April 2008 and December 2010.Twenty consecutive patients with CAO underwent spirometry, IOS, computed tomography, MMRC dyspnea assessment and bronchoscopy before and after interventional bronchoscopy.
Management information
Registered date
| 2011 | Year | 03 | Month | 26 | Day |
Last modified on
| 2013 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006324
