![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | brain tumor, cavernous angioma | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |