UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031786