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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029108
Receipt No. R000033290
Scientific Title Comparison of recording methods for ocular movement stimulated by electrical stimulation as intraoperative monitoring during endoscopic trans-sphenoidal surgery for pituitary tumor
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/12

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Basic information
Public title Comparison of recording methods for ocular movement stimulated by electrical stimulation as intraoperative monitoring during endoscopic trans-sphenoidal surgery for pituitary tumor
Acronym Comparative study for ocular movemenet recording
Scientific Title Comparison of recording methods for ocular movement stimulated by electrical stimulation as intraoperative monitoring during endoscopic trans-sphenoidal surgery for pituitary tumor
Scientific Title:Acronym Comparative study for ocular movemenet recording
Region
Japan

Condition
Condition pituitary tumor
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare detection rate of ocular movement among three modalities.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of ocular movement during surgery
Key secondary outcomes Detection rate of postoperative ocular movement disorder at postoperative day 1, day 7, and day 30

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Induction and recording of ocular movement
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 pituitary tumor undergoing endoscopic transsphenoidal surgery
Key exclusion criteria the patients with irreversible ocular movement disorder, epilepsy, and severe psychiatric disorder
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Motoyama
Organization Nara Medical University
Division name Neurosurgery
Zip code
Address 840 Shijo-cho, Kashihara, Nara, Japan
TEL 0744-29-8866
Email myasushi@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Motoyama
Organization Nara Medical University
Division name Neurosurgery
Zip code
Address 840 Shijo-cho, Kashihara, Nara, Japan
TEL 0744-29-8866
Homepage URL
Email myasushi@naramed-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Nara Medical University
Institute
Department

Funding Source
Organization Department of Neurosurgery, Nara Medical University
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 奈良県立医科大学 脳神経外科

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 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
2017 Year 09 Month 12 Day
Last modified on
2017 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033290

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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