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Long-term 5-year safety and effectiveness clinical outcomes are presented from the RefluxStop CE mark trial, used in an FDA PMA submission. This comprehensive and meticulously controlled data are, therefore, presented across multiple reports with other outcomes in a separate complementary article.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>A prospective, single-arm, multicenter clinical study was conducted to investigate RefluxStop surgery in 50 adults with chronic GERD, PPI use, GERD-HRQL score, 24-h pH testing, contrast-swallow x-ray, and serious\/non-serious AEs presented.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Forty-four (<jats:italic>n<\/jats:italic>\u2009=\u200944) subjects completed 5-year follow-up, whereof 91% underwent pH testing and contrast-swallow x-ray. Three subjects were withdrawn due to COVID-19 (two deaths and one long-COVID), all well-treated beforehand, at 3\u20134\u00a0years. PPI usage (including COVID-19 subjects) in 1\/47 (2.1%). The median (IQR) total GERD-HRQL score improved by 90% (72\u201398%) from a baseline of 29.5 (33.0\u201324.0) to 3.0 (0.5\u20137.5) at 5\u00a0years (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) and 24-h pH monitoring results improved by 90.4% to a mean total acid exposure time (pH\u2009&lt;\u20094) of 1.57% from 16.35% at baseline (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). No cases (0%) of device explantation, migration\/erosion, or esophageal dilatation occurred during the study. Five-year contrast-swallow x-ray showed zero (0%) dislocations, migrations, or re-herniations. Five subjects (<jats:italic>n<\/jats:italic>\u2009=\u20095) experienced serious AEs of which all were resolved. Only two procedure-related AEs occurred between 1 and 5\u00a0years, one moderate dyspepsia and one mild dysphagia, subsequently resolved.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>The RefluxStop procedure demonstrated exceptional long-term 5-year outcomes. Only one subject took PPIs at follow-up. Both median GERD-HRQL scores and mean 24-h pH results improved by\u2009&gt;\u200990% from baseline (<jats:italic>p<\/jats:italic>\u2009=\u20090.001). No device-related AEs, explantations, or migrations occurred during the 5-year study. Only two procedure-related AEs occurred between 1 and 5\u00a0years, one dyspepsia and one mild dysphagia (resolved). These objective and patient-reported results were robustly maintained from previously published 1- to 4-year data.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00464-025-11979-9","type":"journal-article","created":{"date-parts":[[2025,7,22]],"date-time":"2025-07-22T16:06:23Z","timestamp":1753200383000},"page":"6163-6179","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: a prospective multicenter trial of safety and effectiveness"],"prefix":"10.1007","volume":"39","author":[{"given":"L\u00e1szl\u00f3","family":"Hars\u00e1nyi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zsolt","family":"Kincses","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milan","family":"Veselinovi\u0107","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joerg","family":"Zehetner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1ron","family":"Altorjay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,7,22]]},"reference":[{"key":"11979_CR1","doi-asserted-by":"publisher","first-page":"l1580","DOI":"10.1136\/bmj.l1580","volume":"365","author":"Y Xie","year":"2019","unstructured":"Xie Y, Bowe B, Yan Y, Xian H, Li T, Al-Aly Z (2019) Estimates of all cause mortality and cause specific mortality associated with proton pump inhibitors among US veterans: cohort study. 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Drs. L\u00e1szl\u00f3 Hars\u00e1nyi, Zsolt Kincses, Milan Veselinovi\u0107, and \u00c1ron Altorjay declare no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclosures"}}]}}