{"id":74873,"date":"2020-04-10T09:40:34","date_gmt":"2020-04-10T14:40:34","guid":{"rendered":"https:\/\/pulmonx.com\/transform-klinische-studie\/"},"modified":"2021-03-16T13:17:21","modified_gmt":"2021-03-16T18:17:21","slug":"transform-klinische-studie","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/de\/transform-klinische-studie\/","title":{"rendered":"TRANSFORM Klinische Studie"},"content":{"rendered":"\n
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\n \"TRANSFORM-Klinische-Studie\" \n <\/div>\n \n \n <\/div>\n\n
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Die Vorteile entsprechen denen bei der (operativen Lungenvolumenreduktion) LVRS, und die konsistenten Studienergebnisse, die potenzielle Verminderung der Morbidit\u00e4t nach dem Verfahren sowie die Reversibilit\u00e4t des Verfahrens positionieren die Zephyr-Behandlung als tragf\u00e4hige Option bei Patienten, die nach maximaler medikament\u00f6ser Therapie noch symptomatisch bleiben.\u201d2<\/sup><\/a><\/p>\n

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

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Ver\u00f6ffentlicht in The American Journal of Respiratory and Critical Care Medicine2<\/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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    Bei 97 Patienten mit heterogenem Emphysem wurde mit dem Chartis\u00ae<\/sup><\/span>-System best\u00e4tigt, dass sie KV-negativ waren und vermutlich auf die Behandlung mit dem Zephyr-Ventil ansprechen w\u00fcrden. Sie wurden im Verh\u00e4ltnis 2:1 entweder der Behandlung mit dem Zephyr-Ventil oder einer medikament\u00f6sen Behandlung zugewiesen.<\/p>\n<\/li>\n

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    Bei den mit dem Zephyr-Ventil behandelten Patienten erfolgte die Auswahl der Ziellappen auf der Grundlage der Einstufung der emphysembedingten Zerst\u00f6rung und der Beeintr\u00e4chtigung der regionalen Perfusion. Daraufhin erfolgte eine vollst\u00e4ndige Okklusion mit Ventilen.<\/p>\n<\/li>\n

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    Die Klappenposition wurde 45 Tage nach der Implantation mittels CT gepr\u00fcft. Falls erforderlich, wurde die Klappe entfernt bzw. ausgetauscht.<\/p>\n<\/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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    Gr\u00fcnde f\u00fcr Widerruf der Einwilligung<\/h3>\n
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    • 5 Teilnehmer mit dem Zephyr-Ventil vor dem Besuch nach 3 Monaten: 1 mit schwieriger Anatomie zur Implantation des Zephyr-Ventils; 1 mit zwei Pneumothorax-Ereignissen und Verschlechterung der COPD; 2 wegen empfundenem mangelhaftem Nutzen; 1 wegen mangelnder Compliance, Studienausschluss durch den Pr\u00fcfarzt<\/li>\n
    • 1 Teilnehmer mit dem Zephyr-Ventil zwischen dem Besuch nach 3 und nach 6 Monaten: Verschlechterung der COPD, alle Ventile entfernt, Teilnehmer zog Einwilligung zur\u00fcck<\/li>\n
    • 1 Teilnehmer aus der SoC-Gruppe vor dem Besuch nach 3 Monaten: Verlie\u00df die Studie, um au\u00dferhalb der Studie eine Behandlung mit dem Zephyr-Endobronchialventil zu erhalten<\/li>\n<\/ul> <\/div>\n<\/div>\n\n
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      Ergebnisse<\/h2> <\/div>\n<\/div>\n
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      Prim\u00e4rer Endpunkt<\/h4>\n

      Prozentualer Anteil der Teilnehmer, die eine Verbesserung der FEV1<\/sub> (l) um mindestens 12 % erzielten<\/p> <\/div>\n<\/div>\n\n

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#FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html><\/h5> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-2 tb_n16j714 last\">\n <!-- module text -->\n<div class=\"module module-text tb_vc4f714 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Abb. 2d: Verbesserung im SGRQ<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>Case Study Page TRANSFORM - German: TRANSFORM - 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\" 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32<\/h5>\n<h6 class=\"p1\">Legende zu Abb. 2: Die angegebenen Daten sind Mittelwerte \u00b1 SEM der \u00c4nderungen gegen\u00fcber Baseline nach 3 und 6 Monaten nach der Bronchoskopie f\u00fcr das Zephyr-Ventil, den Behandlungsstandard (SoC) und den Unterschied zwischen dem Zephyr-Valve und dem SoC. Abb. 2a: FEV<span class=\"s1\">1<\/span> (l); Abb. 2b: 6-Minuten-Gehstrecke (m) Abb. 2c: RV (l) Abb. 2d: St. George\u2018s Respiratory Fragebogen: und Abb. 2e: BODE-Index<\/h6> <\/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_kgi885\">\n <div data-lazy=\"1\" class=\"module_column sub_column col-full tb_gf5k87 first\">\n <!-- 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>Die Behandlung mit dem Zephyr<sup>\u00ae<\/sup>-Endobronchialventil f\u00fchrt bei Patienten mit heterogenem Emphysem und Lungen\u00fcberbl\u00e4hung ohne Kollateralventilation im Ziellappen gegen\u00fcber der aktuellen medizinischen Standardtherapie zu einem klinisch bedeutsamen und statistisch signifikanten Nutzen in Bezug auf die Lungenfunktion, die Atmungsbeschwerden, die k\u00f6rperliche Belastungsf\u00e4higkeit 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":75051,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[47],"tags":[],"class_list":["post-74873","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 v27.0 - 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