Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting

Brief summary (registry, in English)

Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. The risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination. Artificial intelligence seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis. The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC).

What you commit to

• Study type: Interventional
• Participants enrolled: 900
• From 4 May 2020 to the primary completion date, 31 Oct 2023
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 50 years to 69 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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