UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031217
Receipt number R000034217
Scientific Title Clinical trials for efficacy and safety for a novel device intermediating traditional needle electrodes to BIS-VISTA system for frontal neurosurgical procedure
Date of disclosure of the study information 2018/02/09
Last modified on 2018/05/08 10:52:09

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Basic information

Public title

Clinical trials for efficacy and safety for a novel device intermediating traditional needle electrodes to BIS-VISTA system for frontal neurosurgical procedure

Acronym

Intermediating deice trial for BIS VISTA

Scientific Title

Clinical trials for efficacy and safety for a novel device intermediating traditional needle electrodes to BIS-VISTA system for frontal neurosurgical procedure

Scientific Title:Acronym

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

1st name
Middle name
Last name Hideki Harada

Organization

Kurume University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

Asahimachi 67, Kurume, Fukuoka

TEL

0942353311

Email

hidehara@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Harada

Organization

Kurume University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

Asahimachi 67, Kurume, Fukuoka

TEL

0942353311

Homepage URL


Email

hidehara@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2017 Year 01 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name