NCT07127471

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,090

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Nov 2025

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Nov 2025Jul 2027

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 17, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

August 11, 2025

Last Update Submit

November 17, 2025

Conditions

Sessile Colonic PolypSerrated LesionSessile Serrated LesionColon Adenomas

Outcome Measures

Primary Outcomes (1)

  • Clinically significant serrated lesion (CSSL) detection rate

    Percentage of patients who have 1 or more histologically confirmed CSSLs, including sessile serrated lesions, traditional serrated adenomas, hyperplastic polyps measuring ≥10 mm anywhere in the colon, or hyperplastic polyps measuring 6-9 mm in the proximal colon (cecum to splenic flexure).

    One week (after the colonoscopy procedure, when pathology report is released)

Secondary Outcomes (5)

  • Sessile serrated lesion (SSL) detection rate

    One week (after the colonoscopy procedure, when pathology report is released)

  • Proximal serrated lesion detection rate

    One week (after the colonoscopy procedure, when pathology report is released)

  • High-risk neoplasm detection rate

    One week (after the colonoscopy procedure, when pathology report is released)

  • Adenoma detection rate

    One week (after the colonoscopy procedure, when pathology report is released)

  • Adenoma per colonoscopy

    One week (after the colonoscopy procedure, when pathology report is released)

Study Arms (2)

Water exchange with AI-assisted detection

ACTIVE COMPARATOR

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

Water exchange with AI-assisted detection and LCI

EXPERIMENTAL

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.

Device: Water exchange with AI-assisted detection and LCI

Interventions

Water exchange with AI-assisted detectionDEVICE

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
Water exchange with AI-assisted detection and LCIDEVICE

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.

Water exchange with AI-assisted detection and LCI

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Montreal Medical Center (CHUM)

Montreal, Quebec, H2X 0A9, Canada

NOT YET RECRUITING

Ospedale Valduce

Como, 22100, Italy

NOT YET RECRUITING

Evergreen General Hospital

Taoyuan District, 320, Taiwan

RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

NOT YET RECRUITING

Related Publications (2)

  • Anderson JC, Hisey W, Mackenzie TA, Robinson CM, Srivastava A, Meester RGS, Butterly LF. Clinically significant serrated polyp detection rates and risk for postcolonoscopy colorectal cancer: data from the New Hampshire Colonoscopy Registry. Gastrointest Endosc. 2022 Aug;96(2):310-317. doi: 10.1016/j.gie.2022.03.001. Epub 2022 Mar 8.

    PMID: 35276209BACKGROUND

  • Anderson JC, Rex DK, Mackenzie TA, Hisey W, Robinson CM, Butterly LF. Higher Serrated Polyp Detection Rates Are Associated With Lower Risk of Postcolonoscopy Colorectal Cancer: Data From the New Hampshire Colonoscopy Registry. Am J Gastroenterol. 2023 Nov 1;118(11):1927-1930. doi: 10.14309/ajg.0000000000002403. Epub 2023 Jul 7.

    PMID: 37417792BACKGROUND

Study Officials

  • Chi-Liang Cheng, MD

    Evergreen General Hospital, Taoyuan

    STUDY CHAIR

  • Rungsun Rerknimitr, MD

    Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology, King Chulalongkorn Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Daniel von Renteln, MD

    Research, Gastroenterology Division, University of Montreal Medical Center (CHUM)

    PRINCIPAL INVESTIGATOR

  • Franco Radaelli, MD

    Gastroenterology Unit, Ospedale Valduce

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Liang Cheng, MD

CONTACT

+886 919 768058chiliang.cheng@gmail.com

Rungsun Rerknimitr, MD

CONTACT

+66 81 902 6633ERCP@live.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

November 17, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)TH(1)TW(1)CA(1)