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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010342
Receipt No. R000012098
Scientific Title Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, registry trial
Date of disclosure of the study information 2013/03/28
Last modified on 2013/03/28

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Basic information
Public title Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms;
Multi-center, prospective, registry trial
Acronym Japanese HydroSoft Registry (JHSR)
Scientific Title Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms;
Multi-center, prospective, registry trial
Scientific Title:Acronym Japanese HydroSoft Registry (JHSR)
Region
Japan

Condition
Condition Intracranial aneurysm
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of endovascular treatment using HydroSoft coil for intracranial aneurysm embolization
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Recanalization of endovascular treatment using HydroSoft coil within 1 year
Key secondary outcomes 1) Rebleeding after endovascular treatment using HydroSoft coil within 1 year
2) Major adverse event and death after endovascular treatment using HydroSoft coil within 30 days
3) Retreatment of aneurysm after endovascular treatment using HydroSoft coil within 1 year
4) Any stroke after endovascular treatment using HydroSoft coil within 1 year

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Endovascular treatment using HydroSoft coil
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 1) saccular aneurysm
2) unruptured aneurysm or chronic ruptured aneurysm or acute ruptured aneurysm with WFNS Grade I to III
3) maximum diameter 10mm or less
4) HydroSoft coil 50% or more length used
5) 1 year follow-up possible
Key exclusion criteria 1) previously receive endovascular treatment
2) another aneurysm planned to endovascular treatment
Target sample size 120

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

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Sakai
Organization Institute of Biomedical Research and Innovation
Division name Neuroendovascular
Zip code
Address 2-2 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL 078-304-520
Homepage URL
Email ibri-net@fbri.org

Sponsor
Institute Translational Research Informatics
Institute
Department

Funding Source
Organization Foundation of Biomedical Research and Innovation
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
Address
Tel
Email

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(兵庫県)、中村記念病院(北海道)、広南病院(宮城県)、仙台医療センター(宮城県)、新潟大学(新潟県)、獨協医科大学越谷病院(埼玉県)、虎の門病院(東京都)、順天堂大学(東京都)、名古屋大学(愛知県)、岐阜大学(岐阜県)、三重大学(三重県)、富山大学(富山県)、金沢大学(石川県)、京都大学(京都府)、大阪大学(大阪府)、岡山大学(岡山県)、香川大学(香川県)、徳島大学(徳島県)、山口大学(山口県)、小倉記念病院(福岡県)、九州医療センター(福岡県)、福岡大学(福岡県)、久留米大学(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 28 Day

Related information
URL releasing protocol
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 Open public recruiting
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 06 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 28 Day
Last modified on
2013 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012098

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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