{"id":33,"date":"2020-05-07T22:23:01","date_gmt":"2020-05-08T02:23:01","guid":{"rendered":"https:\/\/dnable.wpengine.com\/ct\/?page_id=33"},"modified":"2021-06-10T11:21:25","modified_gmt":"2021-06-10T15:21:25","slug":"study-protocol","status":"publish","type":"page","link":"\/clinicaltrial-03641677\/about-trial\/study-protocol\/","title":{"rendered":"Pivotal Clinical Study Protocol"},"content":{"rendered":"\t\t
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Study Description<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end-stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge after transplant.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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ClinicalTrials.gov
Identifier: NCT 03641677<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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For additional information, please visit
https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03641677<\/a><\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\tClinicaltrials.gov<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Study Design<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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16<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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TRANSPLANT
CENTER STUDY
SITES\u200b<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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150 patients<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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EVLP Group<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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75<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Control Group<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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75<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Study Objectives<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Primary Endpoint<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t12 months survival\t\t\t\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Secondary ENDPOINTs<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Subject survival at<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t<\/path><\/path><\/g><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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30 Days<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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90 Days<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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6 Months<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Primary Graft Dysfunction (PGD) score (grades 0-3) measured at<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\tPGD<\/span>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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0 HR<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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24 hr<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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48 hr<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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72 hr<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Post-transplant<\/span><\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\tTime to first extubation\t\t\t\t\t<\/span>\n\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\tRate of ECMO use post-transplant\t\t\t\t\t<\/span>\n\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\tICU Length Of Stay (LOS)\t\t\t\t\t<\/span>\n\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\tHospital LOS\t\t\t\t\t<\/span>\n\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Rate of Chronic Lung Allograft Dysfunction (CLAD)<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Rate of respiratory failure<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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FEV\u2081 values at follow-up visits<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Assessment of adverse events<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Data will also be collected on patients who receive a conventional lung transplant. These patients will be enrolled in a contemporaneous control group in order to provide context for EVLP results.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/path><\/g><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\tUtilization rate\t\t\t\t\t<\/span>\n\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\tIncrease in use of donor lungs\t\t\t\t\t<\/span>\n\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\n\t\t\t\t<\/path><\/path><\/g><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\ttotal Preservation time (TPT)\t\t\t\t\t<\/span>\n\t\t\t\t<\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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What is CLES?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The objective of the study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end-stage, survival-limiting lung disease in need of transplantation.<\/p>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\tCLES<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Study Description The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end-stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the […]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":32,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_mi_skip_tracking":false},"yoast_head":"\nLung Bioengineering | Clinical Study Protocol<\/title>\n<meta name=\"description\" content=\"Protocol for clinical study which assesses the safety and effectiveness of CLES in enabling evaluation of potential donor lungs\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"\/clinicaltrial-03641677\/about-trial\/study-protocol\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lung Bioengineering | Clinical Study Protocol\" \/>\n<meta property=\"og:description\" content=\"Protocol for clinical study which assesses the safety and effectiveness of CLES in enabling evaluation of potential donor lungs\" \/>\n<meta property=\"og:url\" content=\"\/clinicaltrial-03641677\/about-trial\/study-protocol\/\" \/>\n<meta property=\"og:site_name\" content=\"EVP-DEV-LTX-301\" \/>\n<meta property=\"article:modified_time\" content=\"2021-06-10T15:21:25+00:00\" \/>\n<meta property=\"og:image\" content=\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/participating-centers-map.svg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Organization\",\"@id\":\"\/clinicaltrial-03641677\/#organization\",\"name\":\"Lung Bioengineering\",\"url\":\"\/clinicaltrial-03641677\/\",\"sameAs\":[],\"logo\":{\"@type\":\"ImageObject\",\"@id\":\"\/clinicaltrial-03641677\/#logo\",\"inLanguage\":\"en-US\",\"url\":\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/LBE_logo_brand-colors.png\",\"width\":330,\"height\":86,\"caption\":\"Lung Bioengineering\"},\"image\":{\"@id\":\"\/clinicaltrial-03641677\/#logo\"}},{\"@type\":\"WebSite\",\"@id\":\"\/clinicaltrial-03641677\/#website\",\"url\":\"\/clinicaltrial-03641677\/\",\"name\":\"Lung Bioengineering CLES Clinical Trial\",\"description\":\"Lung Bioengineering is conducting a clinical trial dedicated to ex vivo lung perfusion as part of our commitment to expanding the supply of available lungs.\",\"publisher\":{\"@id\":\"\/clinicaltrial-03641677\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":\"\/clinicaltrial-03641677\/?s={search_term_string}\",\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"ImageObject\",\"@id\":\"\/clinicaltrial-03641677\/about-trial\/study-protocol\/#primaryimage\",\"inLanguage\":\"en-US\",\"url\":\"\/clinicaltrial-03641677\/wp-content\/uploads\/sites\/3\/2020\/05\/participating-centers-map.svg\"},{\"@type\":\"WebPage\",\"@id\":\"\/clinicaltrial-03641677\/about-trial\/study-protocol\/#webpage\",\"url\":\"\/clinicaltrial-03641677\/about-trial\/study-protocol\/\",\"name\":\"Lung Bioengineering | Clinical Study Protocol\",\"isPartOf\":{\"@id\":\"\/clinicaltrial-03641677\/#website\"},\"primaryImageOfPage\":{\"@id\":\"\/clinicaltrial-03641677\/about-trial\/study-protocol\/#primaryimage\"},\"datePublished\":\"2020-05-08T02:23:01+00:00\",\"dateModified\":\"2021-06-10T15:21:25+00:00\",\"description\":\"Protocol for clinical study which assesses the safety and effectiveness of CLES in enabling evaluation of potential donor lungs\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"\/clinicaltrial-03641677\/about-trial\/study-protocol\/\"]}]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","_links":{"self":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/33"}],"collection":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/comments?post=33"}],"version-history":[{"count":1,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/33\/revisions"}],"predecessor-version":[{"id":546,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/33\/revisions\/546"}],"up":[{"embeddable":true,"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/pages\/32"}],"wp:attachment":[{"href":"\/clinicaltrial-03641677\/wp-json\/wp\/v2\/media?parent=33"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}