UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051516 |
|---|---|
| Receipt number | R000058736 |
| Scientific Title | Middle Meningeal Artery Embolization for recurrent chronic subdural hematoma: a multi-center prospective study in ToKYo |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2025/02/13 10:31:20 |
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Basic information
Public title
Middle Meningeal Artery Embolization for recurrent chronic subdural hematoma in ToKYo
Acronym
MMAE-TKY
Scientific Title
Middle Meningeal Artery Embolization for recurrent chronic subdural hematoma: a multi-center prospective study in ToKYo
Scientific Title:Acronym
MMAE-TKY
Region
| Japan |
Condition
Condition
Recurrent Chronic Subdural Hematoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we prospectively enroll patients who underwent endovascular treatment (Middle Meningeal Artery Embolization: MMAE) for recurrent chronic subdural hematoma. Through evaluating the therapeutic outcomes and exploring the factors influencing these outcomes, we aim to elucidate the challenges by conducting a multi-institutional collaborative research.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
A second recurrence within 90 days following embolization for recurrent chronic subdural hematoma
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
Patients who have undergone MMAE treatment for recurrent chronic subdural hematoma (symptomatic, refractory, progressive) at participating institutions.
Key exclusion criteria
1. Patients whose modified Rankin Scale was 4 or above prior to the onset of neurological symptoms.
2. Any other instances deemed inappropriate for study by the overseeing physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ota |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Neurosurgery
Zip code
183-8524
Address
Musashidai 2-8-29, Fuchu-shi, Tokyo
TEL
042-323-5111
takaota@tama-mail.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Ota |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Neurosurgery
Zip code
183-8524
Address
Musashidai 2-8-29, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
takaota@tama-mail.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Takahiro Ota
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Ethics Committee of Tokyo Metropolitan Tama Medical Center
Address
Musashidai 2-8-29, Fuchu-shi, Tokyo
Tel
042-323-5111
nanako_abe@tmhp.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
東京都立多摩総合医療センター（東京都），国立国際医療研究センター病院（東京都），災害医療センター（東京都），埼玉国際医療センター（埼玉県），埼玉総合医療センター（埼玉県），帝京大学医学部（東京都），東京警察病院（東京都），東京大学医学部（東京都），東京都立墨東病院（東京都），日本医科大学多摩永山病院（東京都），富士脳障害研究所附属病院（静岡県）, JCHO東京新宿メディカルセンター（東京都），三宿病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age, sex, admission date, and date of the surgery and embolization procedure; NIHSS, modified Rankin Scale; neurological findings; blood test results; imaging findings; details of prescribed medication.
Details about the location of the embolized arteries and the type of embolic material utilized; the state of occlusion immediately after the embolization; presence and details of complications resulting from the procedure.
Neurological findings, mRS, and radiographic findings on postoperative day 30 or upon discharge.
Neurological findings, radiographic findings, and presence of postoperative complications on postoperative day 90
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058736
