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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031217
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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