UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022312 |
|---|---|
| Receipt number | R000025707 |
| Scientific Title | Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS) |
| Date of disclosure of the study information | 2016/05/15 |
| Last modified on | 2020/06/29 09:26:14 |
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Basic information
Public title
Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Acronym
Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Scientific Title
Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Scientific Title:Acronym
Computational Fluid Dynamics study for EXploring hemodynamic parameters Predicting REcanalization of cerebral aneurysmS one year after coil embolizationS (CFD-EXPRESS)
Region
| Japan |
Condition
Condition
Cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the hemodynamic parameters predicting recanalization of cerebral aneurysms one-year after coil embolizations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic parameters, shape parameters and embolization parameters that are related to the recanalization one-year after the embolization of cerebral aneurysms
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Unruptured internal carotid artery aneurysms that are embolized with detachable coils between 2013/1/1 and 2017/3/31.
Key exclusion criteria
Aneurysms located in the cavernous sinus.
Aneurysms presenting with neurological symptoms.
Aneurysms embolized with stents.
Aneurysms without pre-operative 3D images.
Aneurysms that were judged to be inappropriate for this study by local investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Shojima |
Organization
The University of Tokyo Hospital
Division name
Department of Neurosurgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan.
TEL
03-5800-8853
mshoji-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Shojima |
Organization
The University of Tokyo Hospital
Division name
Department of Neurosurgery
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan.
TEL
03-5800-8853
Homepage URL
mshoji-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo 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
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
広南病院（宮城県）
神戸中央市民医療センター（兵庫県）
順天堂大学医学部附属順天堂病院（東京都）
東京医科歯科大学医学部附属病院（東京都）
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.dummy.co.jp
Publication of results
Unpublished
Result
URL related to results and publications
http://dummy.co.jp/
Number of participants that the trial has enrolled
0
Results
The research was terminated due to the transfer of the primary investigator.
Results date posted
| 2019 | Year | 11 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter, retrospective and prospective observational study
Management information
Registered date
| 2016 | Year | 05 | Month | 14 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025707
