UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003391 |
|---|---|
| Receipt number | R000003698 |
| Scientific Title | Impulse oscillometry in Interventional bronchoscopy |
| Date of disclosure of the study information | 2010/03/28 |
| Last modified on | 2016/03/28 14:55:25 |
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Basic information
Public title
Impulse oscillometry in Interventional bronchoscopy
Acronym
Impulse oscillometry in Interventional bronchoscopy
Scientific Title
Impulse oscillometry in Interventional bronchoscopy
Scientific Title:Acronym
Impulse oscillometry in Interventional bronchoscopy
Region
| Japan |
Condition
Condition
patients with central airway stensis
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm IOS is useful for the therapy evaluation before and after interventional bronchoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of IOS including R5, R20, X5, X20 and Fres before and after interventional bronchoscopy
Key secondary outcomes
correlation between IOS and spirometry, cross sectional area at the narrowest segment using CT and NEP.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
IOS: to perform 2 times before and after therapy and 2 times during interventional bronchoscopy.
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with central airway stentosis
Key exclusion criteria
one-lunged patients
not to get informed consent with patients e.g. dementia
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 Kanagawa
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
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
| 2010 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Interventional procedures were successfully performed in all subjects. After interventional bronchoscopy, Rrs at all frequencies significantly decreased for TS (p value under 0.01). However, Rrs at all frequencies showed no significant decrease for subjects with UMBS.
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
| 2010 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 28 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003698
