UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055135 |
|---|---|
| Receipt number | R000062409 |
| Scientific Title | National survey on the characteristics of adult pial arteriovenous fistula (a multicenter, retrospective study) |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/31 18:44:44 |
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Basic information
Public title
National survey on the characteristics of adult pial arteriovenous fistula (a multicenter, retrospective study)
Acronym
National survey on characteristics of adult pial AVF
Scientific Title
National survey on the characteristics of adult pial arteriovenous fistula (a multicenter, retrospective study)
Scientific Title:Acronym
National survey on characteristics of adult pial AVF
Region
| Japan |
Condition
Condition
Intracranial pial arteriovenous fistula
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to classify the pathophysiology of adult patients with pial AVF based on history, symptoms, and angiographic findings, to discuss their characteristics and therapeutic effects, and to establish accurate diagnostic and therapeutic methods.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to classify the pathophysiology of adult patients with pial AVF based on history, symptoms, and angiographic findings, to discuss their characteristics and therapeutic effects, and to establish accurate diagnostic and therapeutic methods.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical presentation, patient background, imaging findings, treatment modalities and course of treatment, and neurological prognosis of Pial AVF
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 18 years of age or older with a diagnosis of Pial arteriovenous fistula who visited a participating medical institution between January 1, 2013 and December 31, 2023.
Key exclusion criteria
(i) Patients with insufficient medical information
(ii) Patients whom the principal investigator or subinvestigator deems inappropriate to conduct this study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Akiyama |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3354-8053
akiyamanor@keio.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamada |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3354-8053
Homepage URL
yhiroki08@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
JSNET2024
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
Keio University, ethics committee
Address
35 shinanomachi, Shinjuku, Tokyo, Japan
Tel
0333531211
https://www.ctr.med.keio.ac.jp/forms/
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 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062409
