{"id":74875,"date":"2020-04-10T10:04:55","date_gmt":"2020-04-10T15:04:55","guid":{"rendered":"https:\/\/pulmonx.com\/stelvio-klinische-studie\/"},"modified":"2021-03-16T13:16:45","modified_gmt":"2021-03-16T18:16:45","slug":"stelvio-klinische-studie","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/de\/stelvio-klinische-studie\/","title":{"rendered":"STELVIO Klinische Studie"},"content":{"rendered":"\n
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Die Endobronchialventil-Behandlung zeigte bei Patienten mit Emphysem und nachgewiesener fehlender interlob\u00e4rer Kollateralventilation einen messbaren klinischen Nutzen bei signifikant verbesserter Lungenfunktion, Belastungsf\u00e4higkeit und Lebensqualit\u00e4t im Vergleich zur \u00fcblichen Behandlung.\u201c4<\/sup><\/a><\/p>\n

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Ver\u00f6ffentlicht in The New England Journal of Medicine4<\/a><\/sup><\/h1>\n

Die erste prospektive randomisierte kontrollierte Studie, in der Chartis\u00ae<\/sup> zur Auswahl von Kandidaten f\u00fcr die Behandlung mit dem Zephyr-Endobronchialventil eingesetzt wurde.<\/p>\n

Methodik und Endpunkte<\/b><\/h3>\n
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  • Bei 68 Patienten wurde mit dem Chartis-System best\u00e4tigt, dass sie KV-negativ waren und vermutlich auf die Zephyr\u00ae<\/sup>-Therapie ansprechen w\u00fcrden; sie wurden im Verh\u00e4ltnis 1:1 entweder der Behandlung mit dem Zephyr-Ventil oder einer medikament\u00f6sen Behandlung zugeteilt.<\/li>\n
  • Prim\u00e4re Endpunkte waren die Unterschiede zwischen den Gruppen bez\u00fcglich Ver\u00e4nderungen der FEV1<\/sub>, FVC und 6-Minuten-Gehstrecke (6MWD) vom Baselinebesuch bis zum Besuch nach 6 Monaten.<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n
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    Studiendesign<\/h2> <\/div>\n<\/div>\n\n
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    \n \"STELVIO \n <\/div>\n \n \n <\/div>\n\n
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    * Die STELVIO-Studie war eine unabh\u00e4ngige, \u00e4rztlich initiierte und durchgef\u00fchrte Studie. Pulmonx war an keinem Teil der Studie beteiligt.<\/p> <\/div>\n<\/div>\n\n

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    Ergebnisse<\/h2> <\/div>\n<\/div>\n <\/div>\n <\/div>\n
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    Prim\u00e4rer Endpunkt in der Intention-to-Treat-Gruppe<\/h4>\n

    Mittlere Ver\u00e4nderung vom Baselinebesuch bis zum Besuch nach 6 Monaten<\/p> <\/div>\n<\/div>\n <\/div>\n

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    FEV1<\/sub><\/h5>\n

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background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html><\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col3-1 tb_qd6f385\">\n <!-- module text -->\n<div class=\"module module-text tb_pkwk172 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 class=\"p1\" style=\"text-align: center;\">FVC<\/h5>\n<p style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German: STELVIO - FVC | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" 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class=\"column-2\">Mit dem Zephyr-Ventil behandelte Gruppe<\/td><td class=\"column-3\">SoC<\/td><td class=\"column-4\">\u0394<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\">FEV<sub>1<\/sub><\/td><td class=\"column-2\">+20,9%<\/td><td class=\"column-3\">+3,1%<\/td><td class=\"column-4\">+17,8%<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">FVC<\/td><td class=\"column-2\">+18,3%<\/td><td class=\"column-3\">+4,0%<\/td><td class=\"column-4\">+14,4%<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">6MWD<\/td><td class=\"column-2\">+19,6%<\/td><td class=\"column-3\">-3,6%<\/td><td class=\"column-4\">+23,3%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_ugio625\">\n <div data-lazy=\"1\" class=\"module_column sub_column col-full tb_9zfi627 first\">\n <!-- module text -->\n<div class=\"module module-text tb_06vg821 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h3>Klinischer Nutzen f\u00fcr Teilgruppen mit homogenem Emphysem als auch f\u00fcr solche mit heterogenem Emphysem<\/h3>\n<p>Wirksamkeitsergebnisse f\u00fcr alle mit dem Zephyr-Ventil behandelten Patienten, die die Studie abschlossen. Mittlere Ver\u00e4nderung seit dem Baselinebesuch.<\/p> <\/div>\n<\/div>\n<!-- \/module text --><!-- module text -->\n<div class=\"module module-text tb_f26i346 hide-tablet hide-mobile\" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n \n<table id=\"tablepress-11\" class=\"tablepress tablepress-id-11 stelvio\">\n<tbody class=\"row-striping\">\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">Homogenes Emphysem<br \/>\n(n = 29)<\/td><td class=\"column-3\">Heterogenes Emphysem <br \/>\n(n = 22)<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\">FEV<sub>1<\/sub> (%)<\/td><td class=\"column-2\">+20,1<\/td><td class=\"column-3\">+32,6<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">RV (%)<\/td><td class=\"column-2\">-16,3<\/td><td class=\"column-3\">-16,6<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">6MWD (Meter)<\/td><td class=\"column-2\">+69<\/td><td class=\"column-3\">+72<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">SGRQ (Punkte)<\/td><td class=\"column-2\">-13<\/td><td class=\"column-3\">-19<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n <\/div>\n<\/div>\n<!-- \/module text --><!-- module image -->\n<div class=\"module module-image tb_9gtj639 image-center tf_mw hide-desktop hide-tablet_landscape\" data-lazy=\"1\">\n <div class=\"image-wrap tf_rel tf_mw\">\n <img decoding=\"async\" width=\"1196\" height=\"576\" src=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study.jpg\" class=\"wp-post-image wp-image-80885\" title=\"Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study\" alt=\"Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study\" srcset=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study.jpg 1196w, https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study-300x144.jpg 300w, https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study-1024x493.jpg 1024w, https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Zephyr-Heterogenous-Homogenous-STELVIO-Clinical-Study-768x370.jpg 768w\" sizes=\"(max-width: 1196px) 100vw, 1196px\" \/> \n <\/div>\n <!-- \/image-wrap -->\n \n <\/div>\n<!-- \/module image --><!-- module text -->\n<div class=\"module module-text tb_xhsd472 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h3 class=\"p1\">Signifikant h\u00f6here Ansprechraten bei Patienten, die das Zephyr-Ventil erhalten haben, als mit dem Versorgungsstandard.<\/h3>\n<p class=\"p2\">MCID-Ansprechergebnisse bei Patienten, die die Studie abschlossen.<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_4 tb_ojvn222\">\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_akwx224 first\">\n <!-- module text -->\n<div class=\"module module-text tb_l2lp137 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <p class=\"p1\">Ver\u00e4nderung der FEV<span class=\"s1\"><sub>1<\/sub><\/span><\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_gqfc225\">\n <!-- module text -->\n<div class=\"module module-text tb_vi93559 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Kontrollgruppe<br>n=33<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_r15u364 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German: STELVIO - FEV1 - Control Group | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" 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data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_uy3s998 first\">\n <!-- module text -->\n<div class=\"module module-text tb_7cpn999 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <p class=\"p1\">Ver\u00e4nderung der 6MWD<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_x11u999\">\n <!-- module text -->\n<div class=\"module module-text tb_2si50 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Kontrollgruppe<br>n=33<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_m63841 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German: STELVIO - 6MWD - Control Group | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources 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\"\",\r\n\t\t\t\t\t\t\t\"column-1\": \"53\",\r\n\t\t\t\t\t\t\t\"Color\": \"#3095B4\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t]\r\n\t\t\t\t}\r\n\t\t\t);\r\n\t\t<\/script>\r\n\t<\/head>\r\n\t<body>\r\n\t\t<div id=\"german-stelvio-6mwd-control\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_xfsv0\">\n <!-- module text -->\n<div class=\"module module-text tb_kedb0 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Mit dem Zephyr-Ventil behandelte Gruppe<br>n=25<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_s7o4650 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German: STELVIO - 6MWD - Zephyr Valve | amCharts<\/title>\r\n\t\t<meta name=\"description\" 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last\">\n <!-- module text -->\n<div class=\"module module-text tb_l00m1 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Crossover in die Gruppe zur Behandlung mit dem Zephyr-Ventil<br>n=26<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_aq8q777 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German STELVIO - 6MWD - Crossover | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" 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><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_4 tb_4t40589\">\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_ouuy589 first\">\n <!-- module text -->\n<div class=\"module module-text tb_n5mf334 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <p class=\"p1\">Ver\u00e4nderung im SGRQ<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_ye4z590\">\n <!-- module text -->\n<div class=\"module module-text tb_jufa590 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Kontrollgruppe<br>n=33<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_bgw7256 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German: STELVIO - SGRQ - Control Group | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"german-stelvio-sgrq-control\",\r\n\t\t\t\t{\r\n \t\t\"hidecredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": \"category\",\r\n\t\t\t\t\t\"autoMarginOffset\": 0,\r\n\t\t\t\t\t\"autoMargins\": false,\r\n\t\t\t\t\t\"marginBottom\": 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\"#3095B4\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t]\r\n\t\t\t\t}\r\n\t\t\t);\r\n\t\t<\/script>\r\n\t<\/head>\r\n\t<body>\r\n\t\t<div id=\"german-stelvio-sgrq-control\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_5re9590\">\n <!-- module text -->\n<div class=\"module module-text tb_86n1590 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Mit dem Zephyr-Ventil behandelte Gruppe<br>n=25<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_0oto749 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German: STELVIO - SGRQ - Zephyr Valve | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" 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\"#4F2D7F\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t]\r\n\t\t\t\t}\r\n\t\t\t);\r\n\t\t<\/script>\r\n\t<\/head>\r\n\t<body>\r\n\t\t<div id=\"german-stelvio-sgrq-zephyr\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_sty1592 last\">\n <!-- module text -->\n<div class=\"module module-text tb_pqjj592 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Crossover in die Gruppe zur Behandlung mit dem Zephyr-Ventil<br>n=26<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_ige8781 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page - German: STELVIO - SGRQ - Crossover | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live 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<div class=\"tb_text_wrap\">\n <h2 class=\"p1\">Fazit<\/h2>\n<p class=\"p1\">Die Endobronchialventil-Behandlung f\u00fchrte zu einer signifikanten Verbesserung der Lungenfunktion und Belastungsf\u00e4higkeit bei Patienten mit schwerem Emphysem, das durch fehlende interlob\u00e4re Kollateralventilation gekennzeichnet war.<\/p>\n<p>Zu den Komplikationen in Verbindung mit dem Zephyr-Endobronchialventil k\u00f6nnen u. a. geh\u00f6ren: Pneumothorax, Verschlechterung der COPD-Symptome, H\u00e4moptyse, Lungenentz\u00fcndung, Dyspnoe und in seltenen F\u00e4llen Tod.<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<!--\/themify_builder_content-->","protected":false},"excerpt":{"rendered":"<p>Eine multizentrische, multinationale, randomisierte, kontrollierte Studie mit Zephyr\u00ae-Endobronchialventilen bei Patienten mit heterogenem Emphysem und wenig bis keiner Kollateralventilation.<\/p>\n","protected":false},"author":2,"featured_media":75041,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[47],"tags":[],"class_list":["post-74875","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-klinische-studie","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>STELVIO Klinische Studie - Pulmonx<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pulmonx.com\/de\/stelvio-klinische-studie\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" 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