UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058136 |
|---|---|
| Receipt number | R000066373 |
| Scientific Title | Clinical Utility of Image-Enhanced Endoscopy in Artificial Intelligence-Assisted Endoscopic Diagnosis |
| Date of disclosure of the study information | 2025/06/13 |
| Last modified on | 2025/06/10 10:36:33 |
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Basic information
Public title
Clinical Utility of Image-Enhanced Endoscopy in Artificial Intelligence-Assisted Endoscopic Diagnosis
Acronym
Artificial Intelligence with Linked Color Imaging for Optimal Lesion Recognition/ AI-Color
Scientific Title
Clinical Utility of Image-Enhanced Endoscopy in Artificial Intelligence-Assisted Endoscopic Diagnosis
Scientific Title:Acronym
Clinical Utility of Image-Enhanced Endoscopy in Artificial Intelligence-Assisted Endoscopic Diagnosis
Region
| Japan |
Condition
Condition
Early gastric neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the utility of AI-assisted gastric endoscopy using white light imaging (WLI) and that using linked color imaging (LCI) in the detection of gastric neoplasms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study aims to assess whether LCI significantly reduces the number of false-positive detections while maintaining a tumor detection rate of over 95%.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
During the process of gastric observation, the first upper gastrointestinal endoscopy will be performed using AI-assisted white light imaging (WLI-AI group), followed by a second endoscopic examination using AI-assisted linked color imaging (LCI-AI group).
Interventions/Control_2
During the process of gastric observation, the first upper gastrointestinal endoscopy will be performed using AI-assisted linked color imaging (LCI-AI group), followed by a second endoscopic examination using AI-assisted white light imaging (WLI-AI group).
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 diagnosed with upper gastrointestinal tumors and scheduled to undergo upper gastrointestinal endoscopy and/or treatment under sedation
Male or female patients aged 18 years or older
Patients who have provided written informed consent
Key exclusion criteria
Patients with heart failure or unstable hemodynamics in whom sedation during the procedure is considered unsafe
Patients for whom endoscopy is generally contraindicated (e.g., those with ileus, gastrointestinal perforation, severe respiratory disease, or severe cardiovascular disease)
Patients deemed unsuitable for participation in this study due to serious comorbidities or other medical reasons
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | MINODA |
| Middle name | |
| Last name | YOSUKE |
Organization
Kyushu University Hospital
Division name
Department of Medicine and Bioregulatory Science
Zip code
8518582
Address
maidashi3-1-1, Fukuoka, Japan
TEL
0926425286
minoda.yosuke.633@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoda |
| Middle name | |
| Last name | Yosuke |
Organization
Kyushu University Hospital
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Fukuoka, Japan
TEL
0926425286
Homepage URL
minoda.yosuke.633@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu Univesity
Institute
Department
Personal name
Funding Source
Organization
n/a
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
Kyushu University
Address
3-1-1 Maidashi, Fukuoka, Japan
Tel
0926425286
minoda.yosuke.633@m.kyushu-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
| 2025 | Year | 06 | Month | 13 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066373
