UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046298 |
|---|---|
| Receipt number | R000052169 |
| Scientific Title | Study of prone position MRI for diagnosis of Cerebrospinal fluid hypovolemia |
| Date of disclosure of the study information | 2021/12/07 |
| Last modified on | 2023/03/15 12:57:43 |
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Basic information
Public title
Study of prone position MRI for diagnosis of Cerebrospinal fluid hypovolemia
Acronym
Study of prone position MRI for diagnosis of Cerebrospinal fluid hypovolemia
Scientific Title
Study of prone position MRI for diagnosis of Cerebrospinal fluid hypovolemia
Scientific Title:Acronym
PPM study
Region
| Japan |
Condition
Condition
Cerebrospinal fluid hypovolemia
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of comparison between supine and prone MRI in Cerebrospinal fluid hypovolemia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of dural sac in supine and prone positions
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Cases in which cerebrospinal fluid hypovolemia is suspected due to orthostatic headache
2. 20 years old and over
Key exclusion criteria
1. Patients who cannot be in the prone position
2. Patients who cannot take MRI
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School Hospital
Division name
Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+81888802397
enakai@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School Hospital
Division name
Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+81888802397
Homepage URL
enakai@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan Kouchi
Tel
+81888802180
is21@kochi-u.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
| 2021 | Year | 12 | Month | 07 | 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
12
Results
Twelve patients participated in the study.
The diagnosis of cerebrospinal fluid hypovolemia was confirmed in 6 of the 12 cases.
A change in the shape of the dural sac was confirmed in 3 of the 12 cases.
Results date posted
| 2023 | Year | 03 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2021 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052169
