UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029108 |
|---|---|
| Receipt number | 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 12:39:15 |
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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
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
myasushi@naramed-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033290
