March 16, 2022 – Medtronic announced final findings from a randomized, international, multi-center study that confirmed the effectiveness of the GI Genius™ intelligent endoscopy module, which uses AI as an aid in detecting colorectal polyps during colonoscopy, potentially helping to prevent colorectal cancer (CRC). The study, published on March 15 in Gastroenterology,(opens new window) the official medical journal of the American Gastroenterological Association, found that the use of GI Genius in conjunction with colonoscopy significantly decreases the miss rate (2x) of colorectal polyps and adenomas compared to standard colonoscopy.
In colonoscopies performed as part of the study, adenoma miss rate (AMR) was significantly lower when GI Genius was used as compared to a non-AI-assisted colonoscopy (15.5% vs 32.4%; p-value <0.001). These findings demonstrate that the use of GI Genius during colonoscopy significantly decreases the miss rate of both adenomas and polyps, further confirming the benefit GI Genius adds to colonoscopy procedures.1 The study further found that false negative rates, when a GI Genius-assisted colonoscopy detected adenoma(s) after an initial standard colonoscopy did not, were much lower than that of non-AI-assisted colonoscopies (6.8% vs. 29.6%). In this study, a false negative indicates patients with an initial standard colonoscopy where no adenoma was detected were subsequently found to have at least one adenoma during a second AI-assisted colonoscopy.
The findings confirm topline results of the DETECT study(opens new window) from November 2021 that both AMR and polyp miss rate (PMR) significantly improve when GI Genius is used during colonoscopy. The study was funded by Cosmo Pharmaceuticals, the developer and manufacturer of Medtronic’s GI Genius system.
The study (clinicialtrials.gov identification number: NCT03954548) was conducted in eight centers across the U.S., Italy, and the United Kingdom in university hospitals and community clinics. Study subjects included male and female patients aged 45 or older undergoing a screening or surveillance colonoscopy for colorectal cancer. Overall, 249 subjects were randomized (1:1) in the study, of whom 230 subjects completed the study and were included in the analysis, undergoing two consecutive colonoscopies that were randomly assigned in order of which they were conducted: one with GI Genius and a colonoscopy with white light endoscopy.