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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041998
Receipt No. R000047931
Scientific Title Development of surgery support algorithm in surgical navigation system for neurosurgery
Date of disclosure of the study information 2020/11/30
Last modified on 2020/10/03

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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
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
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
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 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
Registered date File name

Research case data
Registered date File name


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