Water-exchange colonoscopy with AI detection, with or without linked-color imaging, to find serrated colon lesions
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
Run by Evergreen General Hospital, Taiwan · NCT07127471 · Data updated 2026-11-12
This trial tests whether adding linked-color imaging to water-exchange colonoscopy with AI-assisted detection helps doctors find clinically significant serrated lesions in people aged 40–80 having colonoscopy for screening, surveillance, symptoms, or a positive stool test.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 1090 (estimated) |
| Sponsor | Evergreen General Hospital, Taiwan Academic / other |
| Locations | 4 sites (Montreal, Quebec and 3 other locations) |
| Status | Recruiting |
| Started | November 17, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07127471 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40–80 at average colorectal cancer risk who are scheduled for screening, post-polypectomy surveillance, diagnostic colonoscopy for symptoms, or colonoscopy after a positive FIT/gFOBT and who can give informed consent are ideal candidates.
✕Probably not a fit
People with hereditary polyposis syndromes, serrated polyposis, personal history of colorectal cancer, inflammatory bowel disease, prior colonic resection, or other listed exclusion criteria are not eligible and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, unblinded randomized trial comparing two methods for performing water-exchange colonoscopy: AI-assisted computer-aided detection alone (WEAID) versus WEAID combined with linked-color imaging (LCI). Participants aged 40–80 at average colorectal cancer risk undergoing screening, surveillance, diagnostic colonoscopy, or colonoscopy after a positive FIT/gFOBT will be randomized 1:1 with site-stratified opaque-envelope allocation. Both arms use water instead of air for insertion and a standard high-definition colonoscope with an integrated CADe system; the intervention arm adds LCI to the inspection. The primary outcome is the detection rate of clinically significant serrated lesions (CSSL) across four international hospital sites over a two-year recruitment period.
Why it matters
Potential benefit: If successful, adding LCI to AI-assisted water-exchange colonoscopy could increase detection of serrated precancerous lesions and help reduce missed lesions that lead to colorectal cancer.
How similar studies have gone: Previous studies have shown that CADe systems and LCI separately can improve polyp detection and that water-exchange techniques may enhance serrated lesion detection, but combining CADe with LCI in water-exchange colonoscopy is a relatively novel approach with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Evergreen General Hospital
Taoyuan, Taiwan Recruiting -
University of Montreal Medical Center (CHUM)
Montreal, Quebec, Canada Not yet recruiting -
Ospedale Valduce
Como, Italy Not yet recruiting -
King Chulalongkorn Memorial Hospital
Bangkok, Thailand Not yet recruiting
Study contacts
- Principal investigator: Rungsun Rerknimitr, MD — Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology, King Chulalongkorn Memorial Hospital
- Study coordinator: Chi-Liang Cheng, MD
- Email: chiliang.cheng@gmail.com
- Phone: +886 919 768058
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AI-assisted detection and diagnosis of sessile serrated lesions during colonoscopy
A real-time AI detection tool is being tested to see if it helps find sessile serrated lesions during colonoscopy more often than standard white-light exams.
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Using water exchange and CO2 with an abdominal device to ease colonoscopy procedures
This study is testing if using water and a special device during colonoscopy can help make the procedure easier for patients aged 45-80 without needing as much help from medical staff.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.