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

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.

Conditions

• Sessile Colonic Polyp
• Serrated Lesion
• Sessile Serrated Lesion
• Colon 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• King Chulalongkorn Memorial Hospital

  collaborator OTHER

• Ospedale Valduce, Como

  collaborator UNKNOWN

• Evergreen General Hospital, Taiwan

  lead OTHER

Principal Investigators

• Chi-Liang Cheng, MD · Evergreen General Hospital, Taoyuan

• Rungsun Rerknimitr, MD · Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology, King Chulalongkorn Memorial Hospital

• Daniel von Renteln, MD · Research, Gastroenterology Division, University of Montreal Medical Center (CHUM)

• Franco Radaelli, MD · Gastroenterology Unit, Ospedale Valduce

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-11-17

Primary Completion

2027-04-30

Completion

2027-07-31

Countries

• Canada
• Italy
• Taiwan
• Thailand

Study Locations