Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions

NANot yet recruitingINTERVENTIONAL
Enrollment

1,090

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

July 31, 2027

Conditions
Sessile Colonic PolypSerrated LesionSessile Serrated LesionColon Adenomas
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (4)

320

Evergreen General Hospital, Taoyuan District

10330

King Chulalongkorn Memorial Hospital, Bangkok

22100

Ospedale Valduce, Como

H2X 0A9

University of Montreal Medical Center (CHUM), Montreal

All Listed Sponsors
collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

collaborator

King Chulalongkorn Memorial Hospital

OTHER

collaborator

Ospedale Valduce, Como

UNKNOWN

lead

Evergreen General Hospital, Taiwan

OTHER

NCT07127471 - Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions | Biotech Hunter | Biotech Hunter