UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020411 |
|---|---|
| Receipt number | R000020758 |
| Scientific Title | Study of safety and efficacy of dorsal cochlear nucleus action potential (DNAP) monitoring electrode, facial nerve root evoked electromyography (FREEMG) monitoring electrode and monitoring device. |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2017/02/11 15:08:59 |
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Basic information
Public title
Study of safety and efficacy of dorsal cochlear nucleus action potential (DNAP) monitoring electrode, facial nerve root evoked electromyography (FREEMG) monitoring electrode and monitoring device.
Acronym
Study of safety and efficacy of DNAP monitoring electrode, FREEMG monitoring electrode and monitoring device.
Scientific Title
Study of safety and efficacy of dorsal cochlear nucleus action potential (DNAP) monitoring electrode, facial nerve root evoked electromyography (FREEMG) monitoring electrode and monitoring device.
Scientific Title:Acronym
Study of safety and efficacy of DNAP monitoring electrode, FREEMG monitoring electrode and monitoring device.
Region
| Japan |
Condition
Condition
acoustic neuroma, cerebello-pontine angle meningioma, vertebro-basilar aneurysm, cerebello-pontine angle vascular malformation
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of safety and efficacy of dorsal cochlear nucleus action potential (DNAP) monitoring electrode, facial nerve root evoked electromyography (FREEMG) monitoring electrode and monitoring device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intra-operative last DNAP amplitude and last FREEMG amplitude, the ratio of last DNAP amplitude /initial DNAP amplitude and last FREEMG amplitude /initial FREEMG amplitude, postoperative facial nerve grade, postoperative hearing class
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
intraoperative continuous neurophysiological nucleolar and nerve root monitoring electrodes and device
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria.
1. patients who have cerebella-pontine angle lions and are older than 20 years-old.
2. Cerebello^pontine angle lesions include acoustic neuroma, cerebello-pontine angle meningioma, vertebrobasilar aneurysm and cerebello-pontine angle vascular malformation.
Key exclusion criteria
Exclusion those who can not express their decision and intuition.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Nakatomi |
Organization
University of Tokyo Hospital
Division name
Department of Neurosurgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
hnakatomi-tky@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Nakatomi |
Organization
University of Tokyo Hospital
Division name
Department of Neurosurgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
hnakatomi-tky@umin.org
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, 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
| 2015 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 19 | 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
| 2015 | Year | 12 | Month | 31 | Day |
Last modified on
| 2017 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020758
