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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035062
Receipt No. R000039972
Scientific Title Prospective Study of Usefulness of 3-Dimensional Printer Model for Appropriate Microcatheter Shaping during Unruptured Intracranial Aneurysm Coiling
Date of disclosure of the study information 2019/01/10
Last modified on 2019/02/25

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Basic information
Public title Prospective Study of Usefulness of 3-Dimensional Printer Model for Appropriate Microcatheter Shaping during Unruptured Intracranial Aneurysm Coiling
Acronym Unruptured Intracranial Aneurysm 3-Dimensional Printer Model Study
Scientific Title Prospective Study of Usefulness of 3-Dimensional Printer Model for Appropriate Microcatheter Shaping during Unruptured Intracranial Aneurysm Coiling
Scientific Title:Acronym Unruptured Intracranial Aneurysm 3-Dimensional Printer Model Study
Region
Japan

Condition
Condition Unruptured Intracranial Aneurysm
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of cerebral aneurysm 3D-printer model for the appropriate microcatheter shaping
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the microcatheter shaping between 2D image and cerebral aneurysm 3D model
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 First, the microcatheter shaped with 2D-images is insert into the aneurysm. Then, the micro catheter shaped with cerebral aneurysm 3D printer model is insert into the aneurysm. Physicians asses which microcatheter shape was appropriated for the procedure.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with unruptured intracranial aneurysm treated with endovascular coiling at Juntendo University Hospital
Key exclusion criteria Patients determinated to be unsuitable as asubject by researchers.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Oishi
Organization Juntendo University
Division name Department of Neuroendovascular Therapy
Zip code
Address 2-1-1, Bunkyo-ku, Hongo, Tokyo, Japan
TEL +81-3-3813-3150
Email ohishi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Oishi
Organization Juntendo University
Division name Department of Neuroendovascular Therapy
Zip code
Address 2-1-1, Bunkyo-ku, Hongo, Tokyo, Japan
TEL +81-3-3813-3150
Homepage URL
Email ohishi@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 10 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
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039972

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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