{"id":91251,"date":"2019-10-18T09:00:56","date_gmt":"2019-10-18T14:00:56","guid":{"rendered":"https:\/\/pulmonx.com\/transform-clinical-study\/"},"modified":"2024-08-12T12:29:41","modified_gmt":"2024-08-12T17:29:41","slug":"transform-clinical-study","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/uk-en\/transform-clinical-study\/","title":{"rendered":"The TRANSFORM Study"},"content":{"rendered":"\n
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\n \"Zephyr-Valve-Transform-Clinical-Study\" \n <\/div>\n \n \n <\/div>\n\n
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Benefits are in line with those seen with LVRS (lung volume reduction surgery), and the consistent trial results, potential reduction in post-procedure morbidity, and reversibility of the procedure position Zephyr treatment as a viable treatment option in those who remain symptomatic on maximal medical therapy.\u201d2<\/sup><\/a><\/p>\n

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Published in The American Journal of Respiratory and Critical Care Medicine2<\/sup><\/a><\/h1>\n

A multicentre, multinational randomised controlled trial of Zephyr\u00ae<\/sup> Endobronchial Valves in patients with heterogenous emphysema and little to no collateral ventilation<\/p>\n

Methods & Endpoints<\/h3>\n
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    97 patients with heterogeneous emphysema were confirmed with the Chartis\u00ae<\/sup> <\/span>System to be collateral ventilation (CV) negative and likely responders to Zephyr Valve treatment, and randomised 2:1 to either Zephyr Valve treatment or medical management.<\/p>\n<\/li>\n

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    For Zephyr Valve-treated patients, target lobes were selected based on emphysema destruction scores and regional perfusion impairments and were then completely occluded with valves.<\/p>\n<\/li>\n

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    Valve position was assessed at 45 days post-implant by CT and removed and replaced, if necessary.<\/p>\n<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n

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    Study Design<\/h2> <\/div>\n<\/div>\n\n
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    \n \"TRANSFORM-Study-Design\" \n <\/div>\n \n \n <\/div>\n\n
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    Reasons for Withdrawn Consents<\/h3>\n
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    • 5 Zephyr Valve subjects before 3-month visit: 1 difficult anatomy for Zephyr Valve placement; 1 experienced two pneumothoraces and worsening COPD; 2 for lack of perceived benefit; 1 non-compliant, withdrawn by investigator<\/li>\n
    • 1 Zephyr Valve subject between 3- and 6-month visit: Worsening COPD, all valves removed, subject withdrew consent<\/li>\n
    • 1 SoC subject before 3-month visit: Exited study to pursue Zephyr Valve treatment outside of the study<\/li>\n<\/ul> <\/div>\n<\/div>\n\n
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      Results<\/h2> <\/div>\n<\/div>\n
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      Primary Endpoint<\/h4>\n

      Percent of subjects achieving a 12% or greater improvement in FEV1 <\/sub>(L)<\/p> <\/div>\n<\/div>\n\n

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Intent-to-Treat Population<\/h3> <\/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_3 tb_ojvn222\">\n <div data-lazy=\"1\" class=\"module_column sub_column col3-1 tb_akwx224 first\">\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;\">Figure 2a: FEV<sub>1<\/sub> Improvement<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM - 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 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\".17\"\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=\"transform-fev1-line\" style=\"width: 100%; height: 400px; background-color: #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 col3-1 tb_gqfc225\">\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;\">Figure 2b: 6MWD Improvement<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM - 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 type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"transform-6mwd-line\",\r\n\t\t\t\t{\r\n \"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\": 60,\r\n\t\t\t\t\t\"marginLeft\": 76,\r\n\t\t\t\t\t\"sequencedAnimation\": false,\r\n\t\t\t\t\t\"startDuration\": 2,\r\n\t\t\t\t\t\"startEffect\": \"easeOutSine\",\r\n\t\t\t\t\t\"accessibleTitle\": \"changein6mwdmeters\",\r\n\t\t\t\t\t\"backgroundAlpha\": 0.8,\r\n\t\t\t\t\t\"fontFamily\": \"Arial\",\r\n\t\t\t\t\t\"fontSize\": 14,\r\n\t\t\t\t\t\"pathToImages\": 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\"95\",\r\n\t\t\t\t\t\t\t\"Difference Close\": \"58\"\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=\"transform-6mwd-line\" style=\"width: 100%; height: 400px; background-color: #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 col3-1 tb_pdv8225 last\">\n <!-- 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;\">Figure 2c: RV Improvement<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM - RV - 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\" 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\"-.38\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"-.75\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"-.38\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"-.75\",\r\n\t\t\t\t\t\t\t\"Control High\": \".08\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-.12\",\r\n\t\t\t\t\t\t\t\"Control open\": \".08\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.12\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"-.58\",\r\n\t\t\t\t\t\t\t\"Difference High\": \"70\",\r\n\t\t\t\t\t\t\t\"Difference Low\": \"56\",\r\n\t\t\t\t\t\t\t\"Difference Open\": \"70\",\r\n\t\t\t\t\t\t\t\"Difference Close\": \"40\"\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 Months\",\r\n\t\t\t\t\t\t\t\"EBV\": \"-.65\",\r\n\t\t\t\t\t\t\t\"Control\": \"0\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \"-.45\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \"-.80\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"-.45\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"-.80\",\r\n\t\t\t\t\t\t\t\"Control High\": \".15\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-.15\",\r\n\t\t\t\t\t\t\t\"Control open\": \".15\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.15\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"-.65\",\r\n\t\t\t\t\t\t\t\"Difference High\": \"95\",\r\n\t\t\t\t\t\t\t\"Difference Low\": \"58\",\r\n\t\t\t\t\t\t\t\"Difference Open\": \"95\",\r\n\t\t\t\t\t\t\t\"Difference Close\": \"58\"\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=\"transform-rv-line\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html><\/h5> <\/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_3 tb_cruh711\">\n <div data-lazy=\"1\" class=\"module_column sub_column col3-1 tb_aayz713 first\">\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;\">Figure 2d: SGRQ Improvement<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>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\" 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(\"transform-sgrq-line\",\r\n\t\t\t\t{\r\n\t\t\t\t\t\"hideCredits\": \"true\",\r\n \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\": 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\"-7.5\",\r\n\t\t\t\t\t\t\t\"EBV open\": \"-9.7\",\r\n\t\t\t\t\t\t\t\"EBV close\": \"-7.5\",\r\n\t\t\t\t\t\t\t\"Control High\": \"1.2\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-2\",\r\n\t\t\t\t\t\t\t\"Control open\": \"1.2\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-2\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \"-6.8\",\r\n\t\t\t\t\t\t\t\"Difference High\": \"-3.7\",\r\n\t\t\t\t\t\t\t\"Difference Low\": \"-6.8\",\r\n\t\t\t\t\t\t\t\"Difference Open\": \"-3.7\",\r\n\t\t\t\t\t\t\t\"Difference Close\": \"-6.8\"\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=\"transform-sgrq-line\" style=\"width: 100%; height: 400px; background-color: #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 col3-1 tb_n16j714\">\n <!-- module text -->\n<div class=\"module module-text tb_chmi714 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Figure 2e: BODE Index Improvement<\/h5>\n<h5 style=\"text-align: center;\"><!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>TRANSFORM - BODE - 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(\"transform-bode-line\",\r\n\t\t\t\t{\r\n \"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": 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data-lazy=\"1\" class=\"module_column sub_column col3-1 tb_8xnb715 last\">\n <!-- module text -->\n<div class=\"module module-text tb_ev1z715 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5><strong>3 Months<\/strong><br \/>Zephyr Valve n=65, SoC n=32<\/h5>\n<h5><strong>6 Months<\/strong><br \/>Zephyr Valve n=65, SoC n=32<\/h5>\n<h6 class=\"p1\">Legend to Figure 2: Data presented are mean \u00b1 SEM for changes from baseline to 3 and 6 months post bronchoscopy for Zephyr Valve, SoC, and difference between Zephyr Valve and SoC. Figure 2a: FEV<span class=\"s1\">1 <\/span>(L); Figure 2b: 6-Minute Walk Distance (m); Figure 2c: RV (L); Figure 2d: St. George\u2019s Respiratory Questionnaire; and Figure 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\">Conclusion<\/h2>\n<p>Zephyr<sup>\u00ae<\/sup> Valve treatment results in clinically meaningful and statistically significant benefits in lung function, dyspnea, exercise tolerance, and quality of life over current standard of care medical therapy when used in hyperinflated subjects with heterogeneous emphysema without collateral ventilation in the target lobe.<\/p>\n<p>Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.<\/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>A multicenter, multinational randomized controlled trial of Zephyr\u00ae Endobronchial Valves in patients with heterogenous emphysema and little to no collateral ventilation.<\/p>\n","protected":false},"author":2,"featured_media":91253,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[192],"tags":[],"class_list":["post-91251","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-studies-uk-en","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 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>TRANSFORM Clinical Study for Zephyr Valves | Pulmonx<\/title>\n<meta name=\"description\" content=\"The TRANSFORM clinical study was a multicenter, multinational randomized controlled trial of Zephyr\u00ae in patients with heterogenous emphysema.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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