UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056379 |
|---|---|
| Receipt number | R000064418 |
| Scientific Title | MMAE in SH |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2025/05/07 10:46:56 |
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Basic information
Public title
Middle meningeal artery embolization in subdural hematoma
Acronym
MMAE in SH
Scientific Title
MMAE in SH
Scientific Title:Acronym
MMAE in SH
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Subdural Hematoma
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the effectiveness of MMAE in SH
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficiecny
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subdural hematoma
2. Used middle meningeal artery embolization
3. RCT
Key exclusion criteria
1. data insufficent
2. Small sample size
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kawashima |
Organization
Osaka Metropolitan University
Division name
Osaka Metropolitan University
Zip code
545-8585
Address
1-4-8 Asahi-machi Abeno-ku, Osaka-shi, 545-8585
TEL
06-6645-3847
toshiyuki1986.331.24ser@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kawashima |
Organization
Department of Neurosurgery
Division name
Department of Neurosurgery,
Zip code
545-8585
Address
1-4-8 Asahi-machi Abeno-ku, Osaka-shi, 545-8585
TEL
06-6645-3847
Homepage URL
toshiyuki1986.331.24ser@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
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
Department of Neurosurgery, Osaka Metropolitan University
Address
1-4-8 Asahi-machi Abeno-ku, Osaka-shi
Tel
06-6645-3847
toshiyuki1986.331.24ser@gmail.com
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
| 2024 | Year | 12 | Month | 06 | 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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064418
