Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detect
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
| Condition(s) | Sessile Colonic Polyp, Serrated Lesion, Sessile Serrated Lesion, Colon Adenomas |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 obstructi |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Evergreen General Hospital, Taiwan |
| Locations | Montreal, Quebec, Canada; Como, Italy; Taoyuan, Taiwan; Bangkok, Thailand |
| Start date | 2025-11-17 |
| NCT ID | NCT07127471 |
| Official listing | https://clinicaltrials.gov/study/NCT07127471 |