UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048158 |
|---|---|
| Receipt number | R000054876 |
| Scientific Title | Evaluation study of the usefulness of endoscopic diagnostic support software with artificial intelligence for ulcerative colitis |
| Date of disclosure of the study information | 2022/06/24 |
| Last modified on | 2024/06/08 16:46:04 |
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Basic information
Public title
Evaluation study of the usefulness of endoscopic diagnostic support software with artificial intelligence for ulcerative colitis
Acronym
AI-UC study
Scientific Title
Evaluation study of the usefulness of endoscopic diagnostic support software with artificial intelligence for ulcerative colitis
Scientific Title:Acronym
AI-UC study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic Diagnostic Support Software (EB-UC2) Evaluate whether the use of EB-UC2 improves the diagnostic accuracy and diagnostic concordance rate for non-experts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in diagnostic accuracy of non-specialist MES diagnosis with and without the use of EB-UC2 when IBD specialist MES diagnosis is the gold standard
Key secondary outcomes
(1) Differences in diagnostic concordance of MES diagnoses of non-specialists with and without the use of EB-UC2 when using IBD specialists' MES diagnosis as the gold standard.
(2) AI's diagnostic accuracy when using IBD specialists' MES diagnosis as the gold standard
(3) Differences in diagnostic accuracy of endoscopists' MES diagnosis when using IBD specialists' MES diagnosis as the gold standard.
(4)Differences in diagnostic concordance of endoscopists' MES diagnosis with non-specialists' MES diagnosis when the MES diagnosis of IBD specialists is the gold standard
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Image of a patient with ulcerative colitis undergoing colonoscopy at Showa University Northern Yokohama Hospital.
Key exclusion criteria
Image of a patient with ulcerative colitis undergoing colonoscopy at Showa University Northern Yokohama Hospital.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Digestive Disease Center, Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
Yokohama
TEL
0459497000
wakamura92@gmail.com
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University Northern Yokohama Hospital Digestive Disease Center
Division name
Digestive Disease Center
Zip code
224-8503
Address
Yokohama
TEL
08031325168
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
IRB of Showa University Northern Yokohama Hospital
Address
Yokohama
Tel
08031325168
yasuharumaeda610@hotmail.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
| 2022 | Year | 06 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The comparison of the accuracy of MES diagnosis by non-specialists with or without the use of MES diagnosis support software EB-UC2 for ulcerative colitis.
Management information
Registered date
| 2022 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054876
