CompletedNot Applicable

Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection

Italy, Taiwan560 participantsStarted 2023-12-18

Plain-language summary

The goal of this clinical trial is to compare the detected adenoma per colonoscopy (APC) in participants undergoing screening, surveillance, and positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT). There will be two arms in this study: WE water control and water plus artificial intelligence (AI). The main question it aims to answer is whether the addition of AI into water exchange (WE) colonoscopy increases APC than WE alone. The control method will use water instead of air inserted into the colon. The study method will use a commercially available AI system plus water during the procedure. Researchers will compare APCs to see if the addition of AI increases detection of adenomas during WE colonoscopy.

Who can participate

Age range45 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female patients aged 45-75 years at average risk for colorectal cancer who plan to undergo colonoscopy for primary screening, postpolypectomy surveillance, and individuals with positive fecal immunochemical test or guaiac fecal occult blood test results. Exclusion Criteria: * Patients with a history of inflammatory bowel disease * Patients with hereditary colorectal cancer syndrome or serrated polyposis syndrome * Patients with a personal history of colorectal cancer * Patients with a history of colorectal resection * Patients with colonic stricture * Patient with severe comorbid illnesses rendering polypectomy unsafe * Patients with colonoscopy contraindications (e.g., acute diverticulitis or toxic megacolon) * Therapeutic colonoscopy (e.g., hemostasis, removal of a large polyp) * Emergent colonoscopy * Pregnant women or those planning pregnancy * Patients unwilling to participate in the study

What they're measuring

Adenoma per colonoscopy

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

Adenoma detection rate

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

Trial details

NCT IDNCT06173258

SponsorEvergreen General Hospital, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-05