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Each of 223 patients had two colonoscopies in a row, one with the software and one without, in random order. When the software came first, the first exam missed 20.12% of the adenomas found across both exams, against 31.25% when the standard exam came first (P=0.0247). The first-pass adenoma detection rate was 50.44% against 43.64%, a difference that was not statistically significant. No device-related adverse events occurred. On 21 July 2022, CMDE concluded that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the people it serves more benefit than risk) and recommended approval. 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Clinical Gastroenterology and Hepatology 20(7):1499-1507.e4 (2022), published online 14 September 2021. doi:10.1016/j.cgh.2021.09.009.","title":"Deep Learning Computer-aided Polyp Detection Reduces Adenoma Miss Rate: A United States Multi-center Randomized Tandem Colonoscopy Study (CADeT-CS Trial)","url":"https://pubmed.ncbi.nlm.nih.gov/34530161/","date":"2021-09-14","written_by":"evaluator","quote":"Patients were enrolled across 4 U.S. academic medical centers from 2019 through 2020."}],"replication":{"produced_by":["The software took the video signal from the endoscope's image processor and marked suspected polyps on a separate monitor.","Each patient had one colonoscopy with the software and one without, in random order.","The trial ran at four clinical institutions outside China."],"must_hold":["Patients are adults having colonoscopy.","The colonoscope is one of the specified models, used in white-light mode.","Endoscopists judge each polyp from the images and the patient's condition and do not decide on the marks alone."],"echoes":[]},"paired_incident":null,"headline":"*EndoScreener* lowered the adenoma miss rate in China's review","metric":"missed 20.12% of adenomas with EndoScreener, against 31.25% without it","comparator":{"against":"Colonoscopy without the software as the first exam, with each patient also having the other exam in tandem","before":"31.25% adenoma miss rate with the standard exam first","after":"20.12% adenoma miss rate with the software first","basis":"measured","quote":"腺瘤漏诊率 20.12% 31.25% 0.0247 11.13% （1.44%，20.82%）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1660271573567013524.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market trial, in which every patient also had the other exam, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration.","source":"https://www.cmde.org.cn/directory/web/cmde/images/1660271573567013524.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document and the evaluators' peer-reviewed study. 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