UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061816 |
|---|---|
| Receipt number | R000070699 |
| Scientific Title | Research and development of AI for landmark recognition in Esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/06 09:53:29 |
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Basic information
Public title
Development of an Artificial Intelligence System for Automatic Recognition of Anatomical Sites During Esophagogastroduodenoscopy
Acronym
CAQ-EGD
Scientific Title
Research and development of AI for landmark recognition in Esophagogastroduodenoscopy
Scientific Title:Acronym
CAQ-EGD
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will develop and validate an endoscopic AI system designed to ensure the comprehensiveness of imaging coverage during esophagogastroduodenoscopy (EGD). By providing physicians with feedback on imaging completeness, this AI is expected to reduce blind spots and decrease the rate of missed gastric cancers. We will evaluate the classification accuracy of the AI for standard anatomical imaging sites of the esophagus, stomach, and duodenum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Classification accuracy of the AI for standard anatomical landmarks of the esophagus, stomach, and duodenum.
Key secondary outcomes
Performance of the image-quality assessment AI for filtering low-quality images; per-site classification accuracy.
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 who underwent EGD at Showa Medical University Northern Yokohama Hospital between January 1, 2020 and October 31, 2025, who did not opt out of the use of their AI-related information.
Key exclusion criteria
(1) Incomplete EGD; (2) limited visualization due to gastric residue; (3) history of esophageal, gastric, or duodenal surgery.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Misawa |
Organization
SHOWA Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama-shi, Kanagawa, Japan
TEL
0459497000
mmisawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Shibuya |
Organization
SHOWA Medical University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama-shi, Kanagawa, Japan
TEL
0459497000
Homepage URL
tswork0603@gmail.com
Sponsor or person
Institute
SHOWA Medical University
Institute
Department
Personal name
Funding Source
Organization
SHOWA Medical 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
SHOWA Medical University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2026 | Year | 06 | Month | 15 | 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
496
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
| 2024 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Single-center retrospective observational study .
Recruitment method: All patients aged 18 years or older who underwent EGD at Showa Medical University Northern Yokohama Hospital between January 1, 2020 and October 31, 2025, who met the inclusion criteria and did not opt out of the use of their AI-related information.
Recruitment (data collection) period: January 1, 2020 to October 31, 2025.
Measured items: Classification accuracy of the AI for standard anatomical landmarks of the esophagus, stomach, and duodenum (using endoscopist-assigned labels as the reference standard); performance of the image-quality assessment AI for filtering low-quality images; per-site accuracy; sex; age.
Management information
Registered date
| 2026 | Year | 06 | Month | 06 | Day |
Last modified on
| 2026 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070699
