UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060514 |
|---|---|
| Receipt number | R000069227 |
| Scientific Title | A Multicenter Retrospective Observational Study on Changes in Detection Accuracy According to Version of Upper Endoscopy Image Diagnosis Support Program for Detection |
| Date of disclosure of the study information | 2026/01/29 |
| Last modified on | 2026/01/29 20:54:39 |
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Basic information
Public title
A Multicenter Retrospective Observational Study on Changes in Detection Accuracy According to Version of Upper Endoscopy Image Diagnosis Support Program for Detection
Acronym
Changes in detection accuracy depending on the version of upper endoscopy AI
Scientific Title
A Multicenter Retrospective Observational Study on Changes in Detection Accuracy According to Version of Upper Endoscopy Image Diagnosis Support Program for Detection
Scientific Title:Acronym
A Multicenter Retrospective Observational Study on Changes in Detection Accuracy According to Version of Upper Endoscopy Image Diagnosis Support Program for Detection
Region
| Japan |
Condition
Condition
Esophageal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the performance of the new version 2.0 of the EW10-EG01 upper endoscopy image diagnosis support program for detection, developed by Fujifilm, from a clinical perspective. Specifically, the EW10-EG01 ver. 1.1 and ver. 2.0 programs will be applied offline and compared using case videos collected in a previous study (UMIN000049887). As a result, we aim to evaluate the effectiveness of the device in improving detection accuracy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
By observation mode (WLI/BLI/LCI), frequency of detection frames (average number per case and average number per unit examination time). However, detection frames generated for target lesions are excluded.
Key secondary outcomes
Sensitivity for target lesions
Number of detection frames generated for each type of detected object (residue, bubbles, mucosal folds, benign polyps, inflammation, erosions, ulcer scars, others)
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
Case videos were recorded for 181 cases (215 lesions) registered in the multi-institutional prospective observational study "Studying the usefulness of an endoscopic image diagnosis support system using artificial intelligence for esophageal cancer" (primary study UMIN000049887).
Key exclusion criteria
Cases of patients who expressed their intention to be excluded from the study after opting out
Cases whose case videos are unsuitable for analysis
Target sample size
181
Research contact person
Name of lead principal investigator
| 1st name | TAKAO |
| Middle name | |
| Last name | MAEKITA |
Organization
Wakayama Medical University Hospital
Division name
Central endoscope section
Zip code
6410012
Address
811-1 Kimiidera, Wakayama City, Wakayama Prefecture, Japan
TEL
0734410627
maekita@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | TAKAO |
| Middle name | |
| Last name | MAEKITA |
Organization
Wakayama Medical University Hospital
Division name
Central endoscope section
Zip code
6410012
Address
811-1 Kimiidera, Wakayama City, Wakayama Prefecture, Japan
TEL
0734410627
Homepage URL
maekita@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama City, Wakayama Prefecture, Japan
Tel
0734410627
maekita@wakayama-med.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 | 01 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The necessary case data (including case videos) have already been collected in the primary study(UMIN000049887). Patient information will be removed from the case data and collected from each participating institution at Wakayama Medical University.
Fujifilm Corporation will perform offline image analysis on the collected case videos using both the EW10-EG01 (ver. 1.1) and EW10-EG01 (ver. 2.0) software, extracting images of areas where the upper endoscopy imaging support program for detection showed a positive result. Patient information will not be sent to Fujifilm Corporation.
Images of areas where the upper endoscopy imaging support program for detection showed a positive result will be sent via Wakayama Medical University to each participating institution, where the detected area will be identified as cancer or a false positive.
The identification results from each participating institution will be compiled at Wakayama Medical University, and the evaluation items described below (such as the frequency of detection frames excluding target lesions and sensitivity to target lesions) will be evaluated.
Contributing Researchers
Mikitaka Iguchi, Wakayama Medical University
Shinya Taki, Wakayama Medical University
Fumiaki Kuwashima, Wakayama Medical University
Masateru Takao, Wakayama Medical University
Yosuke Mukai, Wakayama Medical University
Masayuki Kitano, Wakayama Medical University
Collaborating Research Institutions
Yoshiro Kawahara, Okayama University Hospital
Motohiko Kato, Keio University
Akihito Nagahara, Juntendo University Hospital, Juntendo University School of Medicine
Kazuhiro Furukawa, Nagoya University Hospital
Shiro Oka, Hiroshima University
Yuichi Teramura, Fujifilm Corporation
Management information
Registered date
| 2026 | Year | 01 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069227
