UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trials for efficacy and safety for a novel device intermediating traditional needle electrodes to BIS-VISTA system for frontal neurosurgical procedure
Title of the study (Brief title)	Intermediating deice trial for BIS VISTA
Region	Japan

Condition
Condition	General Anesthesia cases management with processed EEG monitoring
Classification by specialty	Orthopedics Anesthesiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Estimation of A novel device intermediating traditional needle electrodes to BIS-VISTA system
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	EEG wave, BIS related Values, EMG
Key secondary outcomes	Damages at the needle penetration area

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	BIS related values detected between standard BIS sensor and needle electrodes connected with new device during general anesthesia.
Interventions/Control_2	BIS related values detected between standard BIS sensor and needle electrodes connected with new device during general anesthesia.
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 with ASA classification 1-2 Patients consented to participate in this study
Key exclusion criteria	Altered levels of consciousness before the surgery due to intracranial disorders,neurological disorders,psychiatric disorders;pathergy test positive;metal hypersensitivity.
Target sample size	20

Research contact person
Name of lead principal investigator	Hideki Harada
Organization	Kurume University School of Medicine
Division name	Department of Anesthesiology
Address	Asahimachi 67, Kurume, Fukuoka
TEL	0942353311
Email	hidehara@med.kurume-u.ac.jp

Public contact
Name of contact person	Hideki Harada
Organization	Kurume University School of Medicine
Division name	Department of Anesthesiology
Address	Asahimachi 67, Kurume, Fukuoka
TEL	0942353311
Homepage URL
Email	hidehara@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	self funding
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	2018 Year 02 Month 09 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 10 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 09 Day
Last modified on	2018 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034217