UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002403 |
|---|---|
| Receipt number | R000002291 |
| Scientific Title | Evaluation of Central Airway Stenosis using impulse oscillation system |
| Date of disclosure of the study information | 2009/08/30 |
| Last modified on | 2013/07/29 08:52:40 |
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Basic information
Public title
Evaluation of Central Airway Stenosis using impulse oscillation system
Acronym
Evaluation of Central Airway Stenosis using impulse oscillation system
Scientific Title
Evaluation of Central Airway Stenosis using impulse oscillation system
Scientific Title:Acronym
Evaluation of Central Airway Stenosis using impulse oscillation system
Region
| Japan |
Condition
Condition
Cases of central airway stenosis
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if the impulse oscillation system measurements were related to spirometry for central airway stenosis cases and if feasable for during pre- and post-operative examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between Impulse oscillation system and spirometry
Key secondary outcomes
Evaluation of airway collapsibility and compliance
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 central airway stenosis
Key exclusion criteria
Low volume or poor breathing at rest, incapable of spirometry, tracheostomy
Target sample size
30
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,Kanagawa,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,Kanagawa,Japan
TEL
044-977-8111
Homepage URL
hiroshihstv@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of internal medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of internal 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（神奈川）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 30 | 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
In patients with tracheal stenosis, there were not significant correlation between IOS and spirometry. Patients with bronchial stenosis showed significant correlation between IOS and spirometry.
In 13 patients with malignant airway stenosis, the cross-sectional area at the narrowest segment revealed significant correlation with PEF, R5, R20 and X20.
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
| 2009 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2009 | Year | 08 | Month | 30 | 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=R000002291
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
