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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000038869
Receipt No. R000044326
Scientific Title Japanese Registry of Neuroendovascular Therapy 4
Date of disclosure of the study information 2019/12/13
Last modified on 2020/06/07

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Basic information
Public title Japanese Registry of Neuroendovascular Therapy 4
Acronym JR-NET4
Scientific Title Japanese Registry of Neuroendovascular Therapy 4
Scientific Title:Acronym JR-NET4
Region
Japan

Condition
Condition Neurological Disease
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate technical success and safety of neuro-endovascular therapy in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes modified Rankin Scale at 30 days after treatment
Key secondary outcomes 1 technical sacssess
2 adverse event within 30 days after treatment
3 related complication within 30 days after treatment

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 1 treated by JSNET board certified specialist
2 treated on 2015/1/1 to 2019/12/31
3 30 days after treatment
Key exclusion criteria no limitation
Target sample size 50000

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code 650-0047
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL 078-302-4321
Email n.sakai@siren.ocn.ne.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code 650-0047
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL 078-302-4321
Homepage URL http://www.jrnet.umin.jp/
Email rinken@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Translational Research Informatics
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe City Medical Center General Hospital
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel 078-302-4321
Email rinken@kcho.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 神戸市立医療センター中央市民病院、九州大学、筑波大学、京都大学、他

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 13 Day

Related information
URL releasing protocol http://www.jrnet.umin.jp/
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 Terminated
Date of protocol fixation
2019 Year 11 Month 11 Day
Date of IRB
2019 Year 11 Month 21 Day
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study endorsed by Japanese Society of Neuoendovascular Therapy

Management information
Registered date
2019 Year 12 Month 13 Day
Last modified on
2020 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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