UMIN-CTR Clinical Trial

Basic information
Public title	Development of surgery support algorithm in surgical navigation system for neurosurgery
Acronym	Development of surgery support algorithm in surgical navigation system for neurosurgery
Scientific Title	Development of surgery support algorithm in surgical navigation system for neurosurgery
Scientific Title:Acronym	Development of surgery support algorithm in surgical navigation system for neurosurgery
Region	Japan

Condition
Condition	brain tumor, cavernous angioma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this project is to develop a comprehensive neuro-navigation system using artificial intelligence (AI) in order to help the neurological surgery. Thanks to this system, expert neurosurgery would be available without the ability of the skillful surgeons in any institution, which could lead to the favorable clinical outcome of neurological surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Neuro-navigation system
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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Aged 18 to 75 years old 2) The patients who are planned to take a surgery for brain tumors or angiomas
Key exclusion criteria	1) Age less than 18 years 2) Adults who have no ability to judge 3) Persons who have no consciousness
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kazuya Middle name Last name Motomura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	466-8550
Address	Nagoya
TEL	0527442353
Email	kmotomura@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Kazuya Middle name Last name Motomura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	466-8550
Address	Nagoya
TEL	0527442353
Homepage URL
Email	kmotomura@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Neurosurgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Neurosurgery, Nagoya University Graduate School of Medicine
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	The institutional review board at Nagoya University Hospital
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel	052-744-2061
Email	ethics@med.nagoya-u.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

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 11 Month 30 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This project is medical-engineering-industrial collaborative research. It involves the total two high volume centers for neurosurgery, including Nagoya University hospital; Hitachi, Ltd. which has expertise in developing software for neurological surgery.

Management information
Registered date	2020 Year 10 Month 03 Day
Last modified on	2020 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047931

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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