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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023589
Receipt No. R000027166
Scientific Title Acoustic neuroma surgery using continuous direct neurophysiological monitoring
Date of disclosure of the study information 2016/08/15
Last modified on 2018/02/10

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Basic information
Public title Acoustic neuroma surgery using continuous direct neurophysiological monitoring
Acronym Acoustic neuroma surgery using continuous monitoring
Scientific Title Acoustic neuroma surgery using continuous direct neurophysiological monitoring
Scientific Title:Acronym Acoustic neuroma surgery using continuous monitoring
Region
Japan

Condition
Condition Acoustic neuroma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To achieve a better preservation of nerve function using continuous nerve monitoring during acoustic neuroma surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hearing preservation rate
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Dorsal cochlear Nucleus Action Potential(DNAP), Facial nerve Root Evoked Muscle Action Potential (FREMAP)
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 patients with acoustic neuroma
Key exclusion criteria patients without consent or under the age of 20
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Oishi
Organization Keio University School of Medicine
Division name Department of otolaryngology
Zip code
Address 35 Shinanomachi, Shinjuku-ku
TEL 0353633827
Email oishin@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Oishi
Organization Keio University School of Medicine
Division name Department of otolaryngology
Zip code
Address 35 Shinanomachi, Shinjuku-ku
TEL 0353633827
Homepage URL
Email oishin@keio.jp

Sponsor
Institute Keio University School of Medicine, Department of Otolaryngology
Institute
Department

Funding Source
Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 15 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
2016 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 21 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
2016 Year 08 Month 10 Day
Last modified on
2018 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027166

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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