UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043024 |
|---|---|
| Receipt number | R000049102 |
| Scientific Title | Clinical utility after changing of artificial intelligence algorithm for cerebral aneurysm diagnosis: A study of consecutive 10,000 cases |
| Date of disclosure of the study information | 2021/01/16 |
| Last modified on | 2021/01/15 21:39:50 |
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Basic information
Public title
Clinical utility after changing of artificial intelligence algorithm for cerebral aneurysm diagnosis: A study of consecutive 10,000 cases
Acronym
Clinical utility after changing of artificial intelligence algorithm for cerebral aneurysm diagnosis: A study of consecutive 10,000 cases
Scientific Title
Clinical utility after changing of artificial intelligence algorithm for cerebral aneurysm diagnosis: A study of consecutive 10,000 cases
Scientific Title:Acronym
Clinical utility after changing of artificial intelligence algorithm for cerebral aneurysm diagnosis: A study of consecutive 10,000 cases
Region
| Japan |
Condition
Condition
Unruptured cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to confirm the clinical utility of UCA diagnosis by changing the existing AI algorithm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity, false positives
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
From December 2018 to July 2019, we extracted 10,000 MRI scans of patients who underwent brain screening using the Brain Dock system.
Key exclusion criteria
Cases with MRI scans outside of the period between December 2018 and July 2019.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Neurosurgery
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima
TEL
0822575227
fikawa-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Neurosurgery
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima
TEL
0822575227
Homepage URL
fikawa-nsu@umin.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation Japan 2019
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
Clinical Research and Investigational Review Board of the Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima
Tel
082-257-5907
kasumi-kenkyu@office.hiroshima-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 | 01 | Month | 16 | 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
10000
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under analysis and before open
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049102
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
