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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033000
Receipt No. R000037628
Scientific Title Pathophysiological analysis of neurosurgical diseases by using upright-position computed tomography
Date of disclosure of the study information 2018/06/15
Last modified on 2019/06/18

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Basic information
Public title Pathophysiological analysis of neurosurgical diseases by using upright-position computed tomography
Acronym Pathophysiological analysis of neurosurgical diseases by using upright-position computed tomography
Scientific Title Pathophysiological analysis of neurosurgical diseases by using upright-position computed tomography
Scientific Title:Acronym Pathophysiological analysis of neurosurgical diseases by using upright-position computed tomography
Region
Japan

Condition
Condition Neurosurgical diseases(chronic subdural hematoma, brain tumor, hydrocephalus, cerebrospinal fluid hypovolemia, Chiari malformation, skull defect)
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Supine position and sitting position plane CT are performed on patients with neurosurgical disease, and the dynamics of the intracranial environment at the sitting position will be clarified compared with the supine position. After that, the potential risks for changing a head position and the pathophysiology of each neurosurgical diseases are evaluated.
Basic objectives2 Others
Basic objectives -Others Analysis of pathophysiology of neurosurgical diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Distance from foramen magnum to cerebellar tonsil
Moving distance of pineal body
Angle of cerebellar tentorium
Cross-section area of the forth ventricle
Volume of lateral ventricle
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Sitting position computed tomography(CT) is performed in addition to supine position CT
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
89 years-old >=
Gender Male and Female
Key inclusion criteria Patients over 20 years old with neurosurgical diseases(chronic subdural hematoma, brain tumors, hydrocephalus, cerebrospinal fluid hypotension, Chiari malformation, skull bone defect).
Key exclusion criteria 1. pregnant women and women with possibility of pregnancy
2. patients who are not healthy state and cannot undergo sitting-position computed tomography
3. patients who don't consent for this clinical study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Jinzaki
Organization Keio University school of medicine
Division name Radiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Toda
Organization Keio University School of Medicine
Division name Neurosurgery
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Homepage URL
Email todam@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
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 Institutional Review Board of Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
Tel 62014
Email med-rinri-jimu@adst.keio.ac.jp

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 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
2018 Year 06 Month 12 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037628

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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