UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041998 |
|---|---|
| Receipt number | 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 15:52:19 |
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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
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
kmotomura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047931
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
