{"id":74868,"date":"2020-04-10T09:22:52","date_gmt":"2020-04-10T14:22:52","guid":{"rendered":"https:\/\/pulmonx.com\/liberate-klinische-studie\/"},"modified":"2021-03-16T13:15:34","modified_gmt":"2021-03-16T18:15:34","slug":"liberate-klinische-studie","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/de\/liberate-klinische-studie\/","title":{"rendered":"LIBERATE Klinische Studie"},"content":{"rendered":"\n
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\n \"LIBERATE-Klinische-Studie\" \n <\/div>\n \n \n <\/div>\n\n
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\u201eDie Vorteile sind mit denen bei LVRS (Operation zur Reduktion des Lungenvolumens) vergleichbar, jedoch mit einer Verringerung der Morbidit\u00e4t nach dem Verfahren.\u201c1<\/sup><\/a><\/p>\n

\u00a0<\/p>\n<\/blockquote> <\/div>\n<\/div>\n\n

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\n \n Download Studienzusammenfassung <\/a>\n <\/div>\n <\/div>\n\n <\/div>\n
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Ver\u00f6ffentlicht in The American Journal of Respiratory and Critical Care Medicine1<\/a><\/sup><\/h1>\n

Eine multizentrische, multinationale, randomisierte, kontrollierte Studie mit Zephyr\u00ae<\/sup>-Endobronchialventilen bei Patienten mit heterogenem Emphysem und wenig bis keiner Kollateralventilation<\/p>\n

Methodik und Endpunkte<\/h3>\n
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  • Erste multizentrische randomisierte, kontrollierte Studie zur Bewertung der Wirksamkeit und Sicherheit von Zephyr-Endobronchialventilen bei Patienten mit wenig bis keiner Kollateralventilation (KV) \u00fcber bis zu 12 Monate.<\/li>\n
  • 190 Teilnehmer mit \u00dcberbl\u00e4hung (mittlere RV zum Studienbeginn, 225 % des Sollwerts; FEV1<\/sub>, 27 % des Sollwerts; DLCO, 34 % des Sollwerts) 2:1 randomisiert (128 Zephyr-EBV : 62 SoC).<\/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 \"LIBERATE-Studiendesign\" \n <\/div>\n \n \n <\/div>\n\n
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    Ergebnisse im ITT-Kollektiv<\/h2> <\/div>\n<\/div>\n
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    Responder-Analyse bez\u00fcglich des prim\u00e4ren Endpunktes<\/p>\n

    Prozent der Teilnehmer mit FEV1<\/sub>-\u00c4nderung \u2265 15 %<\/h5>\n <\/div>\n<\/div>\n\n
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Fragebogen<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_5lz7540 \" 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 LIBERATE - German: LIBERATE - SGRQ - Line | 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-sgrq-line\",\r\n\t\t\t\t{\r\n \t\t\"hidecredits\": 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\"-1.9\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"-8.8\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"12 Monate\",\r\n\t\t\t\t\t\t\t\"EBV\": \"-8\",\r\n\t\t\t\t\t\t\t\"Control\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \"-6.5\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"-9.5\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"-6.5\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"-9.5\",\r\n\t\t\t\t\t\t\t\"Control High\": \".3\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-.3\",\r\n\t\t\t\t\t\t\t\"Control open\": \".3\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.3\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"-8\"\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-sgrq-line\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --><!-- module text -->\n<div class=\"module module-text tb_as6s700 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Ver\u00e4nderung der 6MWD<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_czlg578 \" 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 LIBERATE - German: LIBERATE - 6MWD - Line | 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 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<\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_gqfc225 last\">\n <!-- module text -->\n<div class=\"module module-text tb_uj4n492 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Ver\u00e4nderung der FEV<sub>1<\/sub><\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_qjpk207 \" 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 LIBERATE - German: LIBERATE - FEV1 - Line | 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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Unterschied zwischen den Gruppen\",\r\n\t\t\t\t\t\t\t\"balloonText\": \"\",\r\n\t\t\t\t\t\t\t\"bullet\": \"triangleUp\",\r\n\t\t\t\t\t\t\t\"dashLength\": 3,\r\n\t\t\t\t\t\t\t\"id\": \"AmGraph-5\",\r\n\t\t\t\t\t\t\t\"lineColor\": \"#FF5C39\",\r\n\t\t\t\t\t\t\t\"lineThickness\": 3,\r\n\t\t\t\t\t\t\t\"markerType\": \"triangleUp\",\r\n\t\t\t\t\t\t\t\"showBalloon\": false,\r\n\t\t\t\t\t\t\t\"title\": \"Unterschied zwischen den Gruppen\",\r\n\t\t\t\t\t\t\t\"valueField\": \"Between Group Difference\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t],\r\n\t\t\t\t\t\"guides\": [],\r\n\t\t\t\t\t\"valueAxes\": [\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"axisFrequency\": 2,\r\n\t\t\t\t\t\t\t\"id\": \"ValueAxis-1\",\r\n\t\t\t\t\t\t\t\"maximum\": 0.25,\r\n\t\t\t\t\t\t\t\"minimum\": -0.1,\r\n\t\t\t\t\t\t\t\"minMaxMultiplier\": 6,\r\n\t\t\t\t\t\t\t\"unit\": \"\",\r\n\t\t\t\t\t\t\t\"autoGridCount\": false,\r\n\t\t\t\t\t\t\t\"gridCount\": 8,\r\n\t\t\t\t\t\t\t\"minVerticalGap\": 39,\r\n\t\t\t\t\t\t\t\"title\": \"Liter (l)\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t],\r\n\t\t\t\t\t\"allLabels\": [\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"id\": \"p<0,001\",\r\n\t\t\t\t\t\t\t\"text\": \"p<0,001\",\r\n\t\t\t\t\t\t\t\"x\": \"76%\",\r\n\t\t\t\t\t\t\t\"y\": \"26%\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t],\r\n\t\t\t\t\t\"balloon\": {\r\n\t\t\t\t\t\t\"borderThickness\": 1\r\n\t\t\t\t\t},\r\n\t\t\t\t\t\"legend\": {\r\n\t\t\t\t\t\t\"enabled\": true,\r\n\t\t\t\t\t\t\"switchable\": false,\r\n\t\t\t\t\t\t\"tabIndex\": 8,\r\n\t\t\t\t\t\t\"valueAlign\": \"left\"\r\n\t\t\t\t\t},\r\n\t\t\t\t\t\"titles\": [],\r\n\t\t\t\t\t\"dataProvider\": [\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"Baseline\",\r\n\t\t\t\t\t\t\t\"EBV\": \"0\",\r\n\t\t\t\t\t\t\t\"Control\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \"0\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"0\",\r\n\t\t\t\t\t\t\t\"Control High\": \"0\",\r\n\t\t\t\t\t\t\t\"Control low\": \"0\",\r\n\t\t\t\t\t\t\t\"Control open\": \"0\",\r\n\t\t\t\t\t\t\t\"Control close\": \"0\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"0\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"45 Tage\",\r\n\t\t\t\t\t\t\t\"EBV\": \".16\",\r\n\t\t\t\t\t\t\t\"Control\": \".003\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \".18\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \".14\",\r\n\t\t\t\t\t\t\t\"EBV open\": \".18\",\r\n\t\t\t\t\t\t\t\"EBV close\": \".14\",\r\n\t\t\t\t\t\t\t\"Control High\": \".02\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-.012\",\r\n\t\t\t\t\t\t\t\"Control open\": \".02\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.012\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \".16\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"6 Monate\",\r\n\t\t\t\t\t\t\t\"EBV\": \".135\",\r\n\t\t\t\t\t\t\t\"Control\": \".005\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \".155\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \".115\",\r\n\t\t\t\t\t\t\t\"EBV open\": \".155\",\r\n\t\t\t\t\t\t\t\"EBV close\": \".115\",\r\n\t\t\t\t\t\t\t\"Control High\": \".021\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-.015\",\r\n\t\t\t\t\t\t\t\"Control open\": \".021\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.015\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \".135\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"12 Monate\",\r\n\t\t\t\t\t\t\t\"EBV\": \".11\",\r\n\t\t\t\t\t\t\t\"Control\": \"-.002\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \".13\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \".09\",\r\n\t\t\t\t\t\t\t\"EBV open\": \".13\",\r\n\t\t\t\t\t\t\t\"EBV close\": \".09\",\r\n\t\t\t\t\t\t\t\"Control High\": \".02\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-.02\",\r\n\t\t\t\t\t\t\t\"Control open\": \".02\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.02\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \".11\"\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-liberate-Change-in-FEV1-Line\" 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>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_1 tb_kgi885\">\n <div data-lazy=\"1\" class=\"module_column sub_column col-full tb_gf5k87 first\">\n <!-- module text -->\n<div class=\"module module-text tb_2smb156 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h3>Sicherheit: Pulmonale schwerwiegende unerw\u00fcnschte Ereignisse (SUE), die bei mindestens 3,0 % der Teilnehmer in einer oder beiden Gruppen auftraten<\/h3> <\/div>\n<\/div>\n<!-- \/module text --><!-- module text -->\n<div class=\"module module-text tb_9jun652 hide-tablet hide-mobile\" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n \n<table id=\"tablepress-9\" class=\"tablepress tablepress-id-9 study tbody-has-connected-cells\" aria-describedby=\"tablepress-9-description\">\n<tbody class=\"row-striping\">\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><td colspan=\"2\" class=\"column-2\">Behandlungsphase<br \/>\n(0\u201345 Tage)<\/td><td colspan=\"2\" class=\"column-4\">Langfristige Periode<br \/>\n(46 Tage \u2013 1 Jahr)<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">Zephyr-Ventil (n=128)<\/td><td class=\"column-3\">SoC (n=62)<\/td><td class=\"column-4\">Zephyr-Ventil (n=122)<\/td><td class=\"column-5\">SoC (n=62)<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Tod<\/td><td class=\"column-2\">3.1%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">0.8%<\/td><td class=\"column-5\">1.6%<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Pneumothorax<\/td><td class=\"column-2\">26.6%*<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">6.6%<\/td><td class=\"column-5\">0%<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">COPD-Exazerbation<\/td><td class=\"column-2\">7.8%<\/td><td class=\"column-3\">4.8%<\/td><td class=\"column-4\">23.0%<\/td><td class=\"column-5\">30.6%<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Pneumonie<\/td><td class=\"column-2\">0.8%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">5.7%<\/td><td class=\"column-5\">8.1%<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">Atemstillstand<\/td><td class=\"column-2\">1.6%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">0.8%<\/td><td class=\"column-5\">3.2%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span id=\"tablepress-9-description\" class=\"tablepress-table-description tablepress-table-description-id-9\">*Statistische Abweichung vom SoC<\/span>\n <\/div>\n<\/div>\n<!-- \/module text --><!-- module image -->\n<div class=\"module module-image tb_13b1442 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=\"1500\" height=\"452\" src=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-Table-German.jpg\" class=\"wp-post-image wp-image-75091\" title=\"LIBERATE-Table-German\" alt=\"LIBERATE-Table-German\" srcset=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-Table-German.jpg 1500w, https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-Table-German-300x90.jpg 300w, https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-Table-German-1024x309.jpg 1024w, https:\/\/pulmonx.com\/wp-content\/uploads\/2020\/04\/LIBERATE-Table-German-768x231.jpg 768w\" sizes=\"(max-width: 1500px) 100vw, 1500px\" \/> \n <\/div>\n <!-- \/image-wrap -->\n \n <\/div>\n<!-- \/module image --><!-- module text -->\n<div class=\"module module-text tb_7lx993 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <ul>\n<li class=\"p1\">Kurzfristig (erste 45 Tage nach dem Verfahren) erh\u00f6hte SUE-Rate unter Behandlung mit dem Zephyr Ventil im Vergleich zur Standardbehandlung<\/li>\n<li class=\"p1\">Langfristig (46 Tage bis 12 Monate) reduzierte SUE-Rate unter Behandlung mit dem Zephyr Ventil im Vergleich zur Standardbehandlung<\/li>\n<li class=\"p1\">Bei 5 der 8 Teilnehmer mit Pneumothorax w\u00e4hrend der l\u00e4ngeren Nachbeobachtung hatte k\u00fcrzlich eine sekund\u00e4re Bronchoskopie zum Austausch und\/oder zur Entfernung des Ventils stattgefunden.<\/li>\n<\/ul> <\/div>\n<\/div>\n<!-- \/module text --><!-- module divider -->\n<div class=\"module tf_mw module-divider tb_gb3g584 solid \" style=\"border-width: 1px;border-color: #3095b4;margin-top: 10px;margin-bottom: 40px;\" data-lazy=\"1\">\n <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div class=\"module module-text tb_u6r8619 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h2 class=\"p1\">Fazit<\/h2>\n<p class=\"p1\">Die Behandlung mit dem Zephyr<sup><span class=\"s1\">\u00ae<\/span><\/sup>-Endobronchialventil f\u00fchrt bei sorgf\u00e4ltig ausgew\u00e4hlten Patienten mit wenig oder keiner Kollateralventilation im Ziellappen gegen\u00fcber der aktuellen medizinischen Standardtherapie \u00fcber einen Zeitraum von bis zu 12 Monaten zu einem klinisch bedeutsamen und statistisch signifikanten Nutzen in Bezug auf die Lungenfunktion, die k\u00f6rperliche Belastungsf\u00e4higkeit, die Atmungsfunktion und die Lebensqualit\u00e4t.<\/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":75056,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[47],"tags":[],"class_list":["post-74868","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>LIBERATE 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\/liberate-klinische-studie\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" 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