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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Evergreen General Hospital, Taiwan • ClinicalTrials.gov ID: NCT07127471

Registry updated: 2026-09-09
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Description

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.

Interventions

  • Water exchange with AI-assisted detection (Device)
    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 (Device)
    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.

Eligibility criteria

Inclusion Criteria: * Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. Exclusion Criteria: * familial adenomatous polyposis and hereditary non-polyposis CRC syndrome * personal history of serrated polyposis syndrome * personal history of CRC * history of inflammatory bowel disease * previous colonic resection * overt gastrointestinal bleeding * emergency colonoscopy or inpatients * planned EMR or ESD of large polyps * colon stricture or obstruction * contraindications to colonoscopy (eg, acute diverticulitis or toxic megacolon) * antithrombotic therapy precluding complete polyp resection * American Society of Anesthesiology classification of physical status \>3 * pregnant women or women planning pregnancy * refusal to provide a written informed consent

Conditions

Sessile Colonic Polyp Serrated Lesion Sessile Serrated Lesion Colon Adenomas

Locations

  • University of Montreal Medical Center (CHUM) — Montreal, Quebec, Canada
  • Ospedale Valduce — Como, Italy
  • Evergreen General Hospital — Taoyuan, Taiwan
  • King Chulalongkorn Memorial Hospital — Bangkok, Thailand
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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