UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061012 |
|---|---|
| Receipt number | R000069818 |
| Scientific Title | Impact of an artificial intelligence assisted diagnostic system on the time required for endoscopists to diagnose colorectal polyps a prospective observational study using still images |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/22 17:59:44 |
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Basic information
Public title
Impact of an artificial intelligence assisted diagnostic system on the time required for endoscopists to diagnose colorectal polyps a prospective observational study using still images
Acronym
CADx-Time study
Scientific Title
Impact of an artificial intelligence assisted diagnostic system on the time required for endoscopists to diagnose colorectal polyps a prospective observational study using still images
Scientific Title:Acronym
CADx-Time study
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To statistically evaluate whether the use of artificial intelligence reduces the time required for endoscopists to diagnose colorectal polyps.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required for the diagnosis of colorectal polyps
Key secondary outcomes
Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of endoscopists for neoplastic lesions.
Proportion of lesions that endoscopists were able to diagnose with high confidence.
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
Patient Inclusion Criteria
Patients who underwent resection of colorectal polyps less than 10 mm that were imaged at the Gastroenterology Center of Showa University Northern Yokohama Hospital between July 1, 2021, and January 31, 2022.
Patients who did not express refusal to participate in this study.
Patients aged over 20 years at the time of examination.
Physician Inclusion Criteria
Physicians working at the Gastroenterology Center of Showa University Northern Yokohama Hospital during the period from the date of approval indicated in the ethics review approval letter issued by the Ethics Committee for Research Involving Human Subjects at Showa University, after obtaining permission to conduct the study from the head of the institution, until December 31, 2024.
Key exclusion criteria
<Patient Exclusion Criteria>
Absence of NBI images.
NBI images are unclear and the lesion cannot be recognized.
Only images containing multiple lesions are available.
Lesions obtained from patients with inflammatory bowel disease.
Lesions obtained from patients with polyposis.
<Physician Exclusion Criteria>
Physicians not working at the Gastroenterology Center of Showa University Northern Yokohama Hospital.
Physicians deemed ineligible at the discretion of the investigators.
Discontinuation Criteria
The study will be discontinued for a participant if any of the following conditions apply during participation:
A request for withdrawal is made by the participant (or their legally authorized representative).
The study is interrupted due to participant-related circumstances (e.g., relocation, transfer to another hospital, busy schedule, or loss to follow-up).
The participant is found to be ineligible after study initiation.
An incidental accident occurs.
An adverse event occurs (including worsening of the primary disease, exacerbation of comorbidities, or complications), and the investigator determines that discontinuation is necessary.
Continuation of the study becomes difficult due to insufficient effect or worsening of symptoms.
A major deviation from the study protocol occurs, rendering evaluation impossible.
Any other reason for which the investigator judges that continuation of the study is inappropriate.
Target sample size
12
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, Kanagawa, Japan
TEL
045-949-7000
mmisawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | YUTARO |
| Middle name | |
| Last name | IDE |
Organization
SHOWA MEDICAL UNIVERSITY NORTHERN YOKOHAMA HOSPITAL
Division name
DIGESTIVE DISEASE CENTER
Zip code
2248503
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
yuutarou-ide@med.showa-u.ac.jp
Sponsor or person
Institute
SHOWA MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SHOWA MEDICAL UNIVERSITY NORTHERN YOKOHAMA HOSPITAL
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
Tel
045-949-7535
irb02syh@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
昭和医科大学横浜市北部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 23 | 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
12
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
| 2023 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 14 | 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
<Patient Inclusion Criteria>
Patients who underwent resection of colorectal polyps less than 10 mm that were imaged at the Gastroenterology Center of Showa University Northern Yokohama Hospital between July 1, 2021, and January 31, 2022.
Patients who did not express refusal to participate in this study.
Patients aged over 20 years at the time of examination.
<Physician Inclusion Criteria>
Physicians working at the Gastroenterology Center of Showa University Northern Yokohama Hospital during the period from the date of approval indicated in the ethics review approval letter issued by the Ethics Committee for Research Involving Human Subjects at Showa University, after obtaining permission to conduct the study from the head of the institution, until December 31, 2024.
Management information
Registered date
| 2026 | Year | 03 | Month | 22 | Day |
Last modified on
| 2026 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069818
