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
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
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
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
