UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025512 |
|---|---|
| Receipt number | R000029368 |
| Scientific Title | Bronchoscopy with new NBI (Narrow Band Imaging) system |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/01/04 14:38:35 |
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Basic information
Public title
Bronchoscopy with new NBI (Narrow Band Imaging) system
Acronym
Bronchoscopy with new NBI (Narrow Band Imaging) system
Scientific Title
Bronchoscopy with new NBI (Narrow Band Imaging) system
Scientific Title:Acronym
Bronchoscopy with new NBI (Narrow Band Imaging) system
Region
| Japan |
Condition
Condition
Lung Lesion(s) Requiring Evaluation
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate outcomes following Bronchoscopy using the new Narrow Band Imaging (NBI) system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic yields
Key secondary outcomes
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
Bronchoscopy using the new Narrow Band Imaging (NBI) system
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases for whom bronchoscopy is performed
1) Diagnosis of pulmonary disease.
2) Written informed consent.
3) Bronchoscopy is indicated.
Key exclusion criteria
Contraindications for bronchoscopy
1) Uncontrolled severe allergies.
2) Organ failure and sepsis.
3) Severe respiratory failure.
4) Any other reason in the judgement of the inversigator to interfere with participation & compliance with protocol.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kazebayashi |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
+81-166-69-3290
kazeba@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kazebayashi |
Organization
Asahikawa Medical University Hospital
Division name
Respiratory Center
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa-shi, Hokkaido, 078-8510 Japan
TEL
+81-166-69-3290
Homepage URL
kazeba@asahikawa-med.ac.jp
Sponsor or person
Institute
Respiratory Center,Asahikawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029368
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
