UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007039 |
|---|---|
| Receipt number | R000008301 |
| Scientific Title | Multicenter study on surgery for cerebrovascular disorder in University of Niigata and affiliated hospitals |
| Date of disclosure of the study information | 2012/01/09 |
| Last modified on | 2012/04/13 19:21:06 |
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Basic information
Public title
Multicenter study on surgery for cerebrovascular disorder in University of Niigata and affiliated hospitals
Acronym
Niigata Cerebrovascular Surgery Study
Scientific Title
Multicenter study on surgery for cerebrovascular disorder in University of Niigata and affiliated hospitals
Scientific Title:Acronym
Niigata Cerebrovascular Surgery Study
Region
| Japan |
Condition
Condition
cerebrovascular disorder
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Registration of all patients undergoing surgery for cerebrovascular diseases in University of Niigata and the affiliated hospitals to clarify the actual state of cerebrovascular surgery.
Basic objectives2
Others
Basic objectives -Others
Clarification of the actual state of cerebrovascular surgery in the area.
This is a retrospective observational study.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
modified Rankin Scale at discharge
Key secondary outcomes
Technical success
Complications due to surgery
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
Surgery for cerebrovascular disorder.
Key exclusion criteria
Surgery for other diseases than cerebrovascular disorders.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiko Fujii |
Organization
Brain Research Institute, University of Niigata
Division name
Department of Neurosurgery
Zip code
Address
1-757, Asahimachidori, Chuoku, Niigata
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Brain Research Institute, University of Niigata
Division name
Department of Neurosurgery
Zip code
Address
1-757, Asahimachidori, Chuoku, Niigata
TEL
Homepage URL
Sponsor or person
Institute
Department of Neurosurgery. Brain Research Institute, University of Niigata
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery. Brain Research Institute, University of Niigata
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
| 2012 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://neurosurg-bri-niigata.jp/index.php
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
This is a retrospective observational study without using human tissue sample.
Management information
Registered date
| 2012 | Year | 01 | Month | 09 | Day |
Last modified on
| 2012 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008301
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
