{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T22:08:59Z","timestamp":1791756539685,"version":"4.3.4"},"reference-count":30,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002424","name":"Fujifilm Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002424","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Digestive Endoscopy"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This pivotal study aimed to evaluate the performance of the CAD\u2010EYE prototype in identifying esophageal squamous cell carcinoma (ESCC) and gastric neoplasm (GN) for regulatory approval of the Pharmaceuticals and Medical Devices Agency in Japan.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This retrospective study utilized image datasets comprising 15 consecutive video frames captured using non\u2010magnifying white\u2010light imaging (WLI), blue laser\/light imaging (BLI), and linked color imaging (LCI). The sensitivity and specificity of the CAD\u2010EYE prototype for successful detection were calculated using the gold standard, which consists of image datasets of neoplastic lesions annotated by experienced endoscopists.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 620, 679, and 682 ESCC datasets were analyzed in the WLI, BLI, and LCI groups, respectively. The sensitivity and specificity of ESCC detection were 85.9% [81.1%\u201390.6%] and 93.3% [90.8%\u201395.7%] in the WLI group, 97.6% [95.6%\u201399.7%] and 92.9% [90.6%\u201395.3%] in the BLI group, and 96.6% [94.2%\u201399.1%] and 93.2% [91.0%\u201395.5%] in the LCI group. The sensitivities for pT1a ESCC were 85.3%, 97.3%, and 97.2% in the WLI, BLI, and LCI groups, respectively. For GN, 841 WLI and 882 LCI datasets were analyzed. The sensitivity, specificity, and specificity in the detection flag of GN detection were 95.5% [92.8%\u201398.1%], 86.1%, and 85.4% [82.6%\u201388.2%] in the WLI group, and 93.9% [91.1%\u201396.7%], 94.4%, and 93.9% [92.0%\u201395.8%] in the LCI group, respectively. The sensitivities for pT1a early gastric cancer were 93.8% and 92.4% in the WLI and LCI groups, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The CAD\u2010EYE prototype demonstrated high sensitivity in detecting ESCC and GN, highlighting its potential as a promising tool for clinical applications.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/den.70015","type":"journal-article","created":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T07:37:04Z","timestamp":1757662624000},"page":"1306-1314","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["A Multicenter Pivotal Study on the Artificial Intelligence System for Neoplastic Lesions Detection in Upper Gastrointestinal Endoscopy"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2736-6921","authenticated-orcid":false,"given":"Seiichiro","family":"Abe","sequence":"first","affiliation":[{"name":"Endoscopy Division National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyasu","family":"Kitagawa","sequence":"additional","affiliation":[{"name":"Endoscopy Division Chiba Cancer Center  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9717-0281","authenticated-orcid":false,"given":"Waku","family":"Hatta","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology Tohoku University Graduate School of Medicine  Sendai 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