UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023434 |
|---|---|
| Receipt number | R000027001 |
| Scientific Title | Prospective cohort study of Bronchial Artery Embolization for hemoptysis |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/03/04 17:59:18 |
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Basic information
Public title
Prospective cohort study of Bronchial Artery Embolization for hemoptysis
Acronym
BAE cohort study
Scientific Title
Prospective cohort study of Bronchial Artery Embolization for hemoptysis
Scientific Title:Acronym
BAE cohort study
Region
| Japan |
Condition
Condition
hemoptysis
Classification by specialty
| Medicine in general | Pneumology | Radiology |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of BAE.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
re-bleeding free time
Key secondary outcomes
safety, re-bleeding rate, bleeding control rate
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 mild-severe hemoptysis or repeated little hemoptysis.
Key exclusion criteria
Having Aortic dissection, aortic aneurysm, dementia, contrast medium-induced nephropathy or shock.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Niwa |
Organization
Matsunami General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Kasamatsu Izumi11, Hashima, Gifu
TEL
058-388-0111
wanikko0714@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Niwa |
Organization
Matsunami General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Kasamatsu Izumi11, Hashima, Gifu
TEL
058-388-0111
Homepage URL
wanikko0714@yahoo.co.jp
Sponsor or person
Institute
Matsunami General Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsunami General Hospital
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
| 2016 | Year | 08 | 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
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will analyze with retrospective data.
Management information
Registered date
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027001
