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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name