Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061012) titled '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' on March 23.
Study Type:
Observational
Primary Sponsor:
Institute - SHOWA MEDICAL UNIVERSITY
Condition:
Condition - colorectal polyp
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To statistically evaluate whether the use of artificial intelligence reduces the time required for endoscopists to diagnose colorectal polyps.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
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.
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 Size - 12
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069818
Disclaimer: Curated by HT Syndication.