UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verifying the accuracy of neuronavigation system affected by the surgical positioning
Title of the study (Brief title)	Accuracy of neuronavigation system
Region	Japan

Condition
Condition	neurosurgical diseases
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the accuracy of the neuronavigation system in each registration methods or each surgical position
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the accuracy of the neuronavigation system registered by intraoperative CT-based auto-registration method compared with conventional surface marge method.
Key secondary outcomes	1. Deviation from the reference points of neuronavigation system registered by surface marge method in each surgical position. 2. Deviation from the reference points of neuronavigation system registered by intraoperative CT-based auto-registration method in each surgical position. 3. Unavailable events of neuronavigation system registered by intraoperative CT-based auto-registration method.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled neurosurgical procedures with neuronavigation system
Key exclusion criteria	1, Patients who can not examine preoperative CT or MRI 2, Patients who can not undertake general anesthesia. 3, Patients who planed neurosurgical procedure without neuronavigation system 4, Pregnant patients
Target sample size	60

Research contact person
Name of lead principal investigator	Toshihiko Kuroiwa
Organization	Osaka Medical College
Division name	Department of Neurosurgery and Endovascular Neurosurgery
Address	2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL	+81-72-683-1221
Email	neu040@osaka-med.ac.jp

Public contact
Name of contact person	Motomasa Furuse
Organization	Osaka Medical College
Division name	Department of Neurosurgery and Endovascular Neurosurgery
Address	2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL	+81-72-683-1221
Homepage URL
Email	neu054@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 07 Month 07 Day
Anticipated trial start date	2016 Year 07 Month 22 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	none

Management information
Registered date	2016 Year 07 Month 21 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026808