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

Recruiting now · Not applicable

Conditions studied: Sessile Colonic Polyp, Serrated Lesion, Sessile Serrated Lesion, Colon Adenomas

In brief

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.

Key facts

Study ID

NCT07127471

Run by

Evergreen General Hospital, Taiwan

People needed

1090

Starts

2025-11-17

Expected to finish

2027-07-31

Last updated by the study team

2025-11-20

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.