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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027862
Receipt No. 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

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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
Email 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
Email kanaya@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine, Department of Neurosurgery
Institute
Department

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
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
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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031786

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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