UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002400 |
|---|---|
| Receipt number | R000002946 |
| Scientific Title | Measurements of lateral pressure using an airway catheter during bronchoscopy |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2019/09/24 16:56:50 |
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Basic information
Public title
Measurements of lateral pressure using an airway catheter during bronchoscopy
Acronym
Lateral pressure measurements of stenosis
Scientific Title
Measurements of lateral pressure using an airway catheter during bronchoscopy
Scientific Title:Acronym
Lateral pressure measurements of stenosis
Region
| Japan |
Condition
Condition
Tracheobronchial stenosis
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the location of flow limiting segments and the outcomes of interventional pulmonology
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the exact location of the flow limiting segment
Key secondary outcomes
To assess quantitatively the degree of tracheobronchial stenosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
For patients with tracheobronchial stenosis.
Point-by-point Plat was measured simultaneously using an airway catheter at all three points during interventional bronchoscopy.
Interventions/Control_2
For control subjects.
Point-by-point Plat was measured simultaneously using an airway catheter at all three points during bronchoscopy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Interventional bronchoscopy is performed in patients with tracheobronchial stenosis.
Key exclusion criteria
Patients with sever pulmonary dysfunction
Patients with unilateral atelectasis
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishine |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL
044-977-8111
h2nishine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishine |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL
044-977-8111
Homepage URL
h2nishine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine, Division of Graduate Student Affairs and Research Promotion
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 01 | 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
95
Results
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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 29 | Day |
Last modified on
| 2019 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002946
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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