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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024961
Receipt No. R000028721
Scientific Title Wada test using propofol
Date of disclosure of the study information 2018/06/11
Last modified on 2018/06/10

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Basic information
Public title Wada test using propofol
Acronym Wada test
Scientific Title Wada test using propofol
Scientific Title:Acronym Wada test
Region
Japan

Condition
Condition Neurosurgical patients who needs Wada test
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to verify the safety to use propofol for wada test
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes adverse effect due to the wada test with propofol such as strokes
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Selective injection of propofol to internal cervical artery
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Clinical need for wada test
Key exclusion criteria age < 18
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takufumi Yanagisawa
Organization Osaka University
Division name Department of Neurosurgery
Zip code
Address 2-2 Yamadaoka Suita, Osaka
TEL 06-6879-3652
Email tyanagisawa@nsurg.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takufumi Yanagisawa
Organization Osaka University
Division name Department of neurosurgery
Zip code
Address 2-2 Yamadaoka, Suita, Japan
TEL 06-6879-3652
Homepage URL
Email tyanagisawa@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization MEXT
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
2018 Year 06 Month 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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
2016 Year 11 Month 23 Day
Last modified on
2018 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028721

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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