UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027862 |
|---|---|
| Receipt number | R000031786 |
| Scientific Title | The efficacy of peg-screw in transcranial MEP |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2019/06/24 21:29:17 |
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Basic information
Public title
The efficacy of peg-screw in transcranial MEP
Acronym
The efficacy of peg-screw in transcranial MEP
Scientific Title
The efficacy of peg-screw in transcranial MEP
Scientific Title:Acronym
The efficacy of peg-screw in transcranial MEP
Region
| Japan |
Condition
Condition
The patient undergoing neurosurgical operation and intraoperative MEP, and impossible of corkscrew placement due to skin incision
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of peg-screw on the skull in intraoperative MEP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
advisability and evaluation of peg-screw in intraoperative MEP
Key secondary outcomes
adverse event in peg-screw placement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Peg-screw placement on the skull in Intraopeative MEP during operation
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
1. over 20 years patients
2. patients' permission for this method
Key exclusion criteria
1. impossible patients in intraoperative neuromonitoring
2. muscle relaxant necessity in operation
3. inhalation anesthesia necessity in operation
4. unacceptable patients for this research
5. patients with allergy for stainless
6. abnormal skull patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Kanaya |
Organization
Shinshu University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
3-1-1 Asahi, Matsumoto 390-8621
TEL
0263-37-2690
kanaya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Kanaya |
Organization
Shinshu University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
3-1-1 Asahi, Matsumoto 390-8621
TEL
0263-37-2690
Homepage URL
kanaya@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine, Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031786
