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Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions
Sponsor: Evergreen General Hospital, Taiwan
Summary
The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.
Official title: A Multicenter Prospective Randomized Controlled Trial of Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions in Computer-Aided Water Exchange Colonoscopy
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1090
Start Date
2025-11-17
Completion Date
2027-07-31
Last Updated
2025-11-20
Healthy Volunteers
Yes
Interventions
Water exchange with AI-assisted detection
The study employs standard high-definition colonoscopy video processors with integrated CADe system (CAD-EYE, EW10-EC02, Fujifilm) The ELUXEO 7000 system (Fujifilm) will be used in this study. During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe device will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe systems, ensuring readiness before study initiation.
Water exchange with AI-assisted detection and LCI
The study employs high-definition colonoscopy video processors with integrated CADe (CAD-EYE, EW10-EC02, Fujifilm) and LCI systems (Fujifilm).The ELUXEO 7000 system will be used . During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe and LCI devices will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe and LCI systems, ensuring readiness before study initiation.
Locations (4)
University of Montreal Medical Center (CHUM)
Montreal, Quebec, Canada
Ospedale Valduce
Como, Italy
Evergreen General Hospital
Taoyuan District, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Thailand