UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022796 |
|---|---|
| Receipt number | R000022839 |
| Scientific Title | establishment of a system of the virtual navigation in neurosurgery |
| Date of disclosure of the study information | 2016/06/21 |
| Last modified on | 2017/12/25 16:48:28 |
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Basic information
Public title
establishment of a system of the virtual navigation in neurosurgery
Acronym
establishment of a system of the virtual navigation in neurosurgery
Scientific Title
establishment of a system of the virtual navigation in neurosurgery
Scientific Title:Acronym
establishment of a system of the virtual navigation in neurosurgery
Region
| Japan |
Condition
Condition
intracranial lesion
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We use a system of the virtual navigation and assesment of its accuracy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
assesment of compliance with preoperative image information
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
| Device,equipment |
Interventions/Control_1
A microsensor is furnished with neuroendoscope in operation, and it gives us the information of location with neuroendoscope.
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patient who has intracranial lesion and is planned for neuroendoscopic surgery
Key exclusion criteria
the patient who rejects our study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeuchi Kazuhito |
Organization
Nagoya university
Division name
Department of neurosurgery,
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi Pref
TEL
052-744-2353
ktakeuchi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chu Jonsu |
Organization
Nagoya university graduate school of medicine
Division name
Department of neurosurgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi Pref
TEL
052-744-2353
Homepage URL
jonsu_the_sankakukin@yahoo.co.jp
Sponsor or person
Institute
Department of neurosurgery of Nagoya university
Institute
Department
Personal name
Funding Source
Organization
supportive budget for advanced study
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Media Science, Graduate School of Information Science, Nagoya University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | 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
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2017 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022839
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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