UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	establishment of a system of the virtual navigation in neurosurgery
Title of the study (Brief title)	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	Takeuchi Kazuhito
Organization	Nagoya university
Division name	Department of neurosurgery,
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi Pref
TEL	052-744-2353
Email	ktakeuchi@med.nagoya-u.ac.jp

Public contact
Name of contact person	Chu Jonsu
Organization	Nagoya university graduate school of medicine
Division name	Department of neurosurgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi Pref
TEL	052-744-2353
Homepage URL
Email	jonsu_the_sankakukin@yahoo.co.jp

Sponsor
Institute	Department of neurosurgery of Nagoya university
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022839