UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033000 |
|---|---|
| Receipt number | 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 | 2022/12/25 08:43:03 |
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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
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
todam@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037628
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
