{"id":"AIBD-0646","title":"Randomized trial at Korea University and Ewha Womans University hospitals: ENAD-DET-01 raises adenoma detection from 36.1% to 52.3%","summary":"In a two-hospital Seoul trial of 998 patients, colonoscopy with Ainex's ENAD-DET-01 found adenomas in 52.3% of patients against 36.1% with standard colonoscopy.","date_observed":"2025-04-01","date_basis":"event","date_precision":"month","benefit_status":"reported","source_collection":null,"source_entry":null,"account":"Gastroenterologists at Korea University College of Medicine and Ewha Womans University College of Medicine ran a randomized trial at two tertiary hospitals in Seoul, South Korea, from May 2023 to April 2025. They randomly assigned 998 adults who had screening, surveillance or diagnostic colonoscopy to colonoscopy with or without ENAD-DET-01, a deep-learning detection system from Ainex Corporation of Seoul. The system draws a circle on the endoscopy monitor when it recognizes a polyp. Adenomas were found in 52.3% of patients in the system group and in 36.1% of the control group. Polyps were found in 72.2% against 54.5%, and the system group had 1.2 adenomas per colonoscopy against 0.8. The system did not raise the detection of sessile serrated lesions or cancers. Both hospitals used the same Olympus endoscopy platform. The Korea Medical Device Development Fund paid for the study, and the authors report no conflicts of interest.","category":"general benefit","unexpected":false,"purpose":"ENAD-DET-01 was built to detect colorectal polyps on the live colonoscopy video. The higher adenoma detection was that purpose.","system":"ENAD-DET-01 (ENdoscopy as AI-powered Device)","model_version":null,"developer":"Ainex Corporation","deployer":"Korea University Medical Center and Ewha Womans University Medical Center","location":"Seoul, South Korea","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"personal","depth":3,"reason":"Adenomas, which are precursors of colorectal cancer, were found and removed in 52.3% of patients with the system against 36.1% without."},{"group":"organizational","depth":2,"reason":"The hospitals raised adenomas found per colonoscopy from 0.8 to 1.2."}],"ai_role":{"status":"assessed","statement":"Patients were randomly assigned to colonoscopy with or without the system, so the difference in detection is attributable to the system."},"evidence":[{"kind":"peer-reviewed study","citation":"Jeon HJ, Keum B, Jeong ES, et al. 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Methods section.","title":"Clinical Efficacy of Real-Time Artificial Intelligence-Assisted Colonoscopy in Colorectal Polyp Detection (methods)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12800677/","date":"2025-11-27","written_by":"independent","quote":"A deep learning-based CADe system (ENAD-DET-01, ENdoscopy as AI-powered Device; Ainex Corporation, Seoul, Korea)"}],"replication":{"produced_by":["The system marked suspected polyps on the live endoscopy monitor.","Endoscopists at two tertiary hospitals used it in screening, surveillance and diagnostic colonoscopy.","The control group's adenoma detection rate was 36.1%."],"must_hold":["The system must run on a compatible endoscopy processor.","Baseline detection must leave room for improvement."],"echoes":[{"date":"2022-10-01","setting":"Cluster-randomized rollout at 42 VA facilities, United States (GI Genius)","model_version":null,"outcome":"recurred","source":"https://pubmed.ncbi.nlm.nih.gov/42250891/"},{"date":"2023-08-01","setting":"Randomized trial at a Japanese community hospital","model_version":null,"outcome":"did not recur","source":"https://pubmed.ncbi.nlm.nih.gov/40611562/"}]},"paired_incident":null,"headline":"*ENAD-DET-01* helps Seoul endoscopists find more adenomas","metric":"found adenomas in 52.3% of patients against 36.1% with standard colonoscopy","comparator":{"against":"Standard colonoscopy without the system","before":"Adenoma detection rate of 36.1%","after":"Adenoma detection rate of 52.3%","basis":"measured","quote":"ADR increased by 16.2% with CADe use (52.3%) compared to the non-CADe group (36.1%)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12800677/"},"later":null,"value":null,"developer_country":"South Korea","deployer_country":"South Korea","unrated_because":null,"brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-29","change":"Added the case.","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12800677/","editor":"AIBD"}],"confidence":"studied","shade":"high","claim_status":"Independently studied","claim_basis":"Sources: one independent peer-reviewed study. 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