CompletedNot Applicable

Artificial Intelligence for Leaving in Situ Colorectal Polyps.

Italy919 participantsStarted 2022-10-01

Plain-language summary

This two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting. With this study it will be possible to understand the impact of CADx in patient treatment and management both in terms of clinical outcome and costs.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion criteria: \- All \>18 years-old patients undergoing elective colonoscopy Exclusion criteria: * patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD). * Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis. * patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment). * patients with previous colonic resection. * patients on antithrombotic therapy, precluding polyp resection. * patients who were not able or refused to give informed written consent.

What they're measuring

Adenoma Detection Rate (ADR)

Timeframe: 1 year

Trial details

NCT IDNCT05500248

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Colonic Neoplasms trials