Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-04-18 @ 5:50 AM
Study NCT ID:
NCT01796392
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nshargill@pulmonx.com', 'phone': '650-216-0108', 'title': 'Narinder Shargill', 'organization': 'Pulmonx Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Zephyr Valve Treatment and Optimal Medical Management', 'description': 'This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nEBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 124, 'seriousNumAtRisk': 128, 'deathsNumAffected': 5, 'seriousNumAffected': 77}, {'id': 'EG001', 'title': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nOptimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 46, 'seriousNumAtRisk': 62, 'deathsNumAffected': 1, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 46, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 99, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 46, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaesthetic complication pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Device expulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 50, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 32, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 42, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Umbilical hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Forced Expiratory Volume in 1-second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zephyr Valve Treatment and Optimal Medical Management', 'description': 'This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nEBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}, {'id': 'OG001', 'title': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nOptimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of \\>15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'FEV1 Post-bronchodilator Absolute Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zephyr Valve Treatment and Optimal Medical Management', 'description': 'This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nEBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}, {'id': 'OG001', 'title': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nOptimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (SGRQ)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zephyr Valve Treatment and Optimal Medical Management', 'description': 'This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nEBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}, {'id': 'OG001', 'title': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nOptimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.6', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '15.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline).\n\nThe St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:\n\nPart I: Symptoms (frequency \\& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)\n\nA Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}, {'type': 'SECONDARY', 'title': '6-minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zephyr Valve Treatment and Optimal Medical Management', 'description': 'This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nEBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}, {'id': 'OG001', 'title': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nOptimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '81.5', 'groupId': 'OG000'}, {'value': '-26.3', 'spread': '81.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).", 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EBV and Optimal Medical Management', 'description': 'This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nEBV: This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}, {'id': 'FG001', 'title': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nOptimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '119 active subjects at 12-months', 'groupId': 'FG000', 'numSubjects': '119'}, {'comment': '59 active subjects at 12-months', 'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Excluded for medical reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zephyr Valve Treatment and Optimal Medical Management', 'description': 'This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nEBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}, {'id': 'BG001', 'title': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.\n\nOptimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.7', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '66.3', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.7', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '24.3', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '24.6', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pack Years Smoking History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.8', 'spread': '26.9', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '28.5', 'groupId': 'BG001'}, {'value': '50.1', 'spread': '27.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.', 'unitOfMeasure': 'pack-years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 Post-Bronchodilator (liters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 Post-Bronchodilator (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.0', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '26.2', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '27.4', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FVC (liters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FVC (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.2', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diffusing Capacity (mL CO/min/mm Hg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL CO / min / mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.'}, {'title': 'Diffusing Capacity (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.6', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '34.1', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%predicted', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.'}, {'title': 'Residual Volume (RV) (liters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.'}, {'title': 'Residual Volume (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '224.5', 'spread': '42.5', 'groupId': 'BG000'}, {'value': '224.6', 'spread': '38.9', 'groupId': 'BG001'}, {'value': '224.5', 'spread': '41.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%predicted', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.'}, {'title': 'Total Lung Capacity (TLC) (liters)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '7.6', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.'}, {'title': 'Total Lung Capacity (% predicted)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '133.5', 'spread': '21.2', 'groupId': 'BG000'}, {'value': '130.2', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '132.4', 'spread': '18.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%predicted', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data.'}, {'title': 'GOLD Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'title': 'GOLD Stage III', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'GOLD Stage IV', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The GOLD system uses the term "stages" to refer to the different levels of COPD. Participants graded as GOLD Stage III are considered to have Severe COPD. Participants graded as GOLD Stage IV are considered to have Very Severe COPD.', 'unitOfMeasure': 'Participants'}, {'title': '6 Minute Walk Distance (m)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '311.3', 'spread': '81.3', 'groupId': 'BG000'}, {'value': '301.9', 'spread': '78.5', 'groupId': 'BG001'}, {'value': '308.3', 'spread': '80.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SGRQ Total score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.2', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:\n\nPart I: Symptoms (frequency \\& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)\n\nA Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 127 EBV subjects and 61 Control subjects were analyzed, due to missing data.'}, {'title': 'mMRC Dyspnea Grade score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '2.4', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects were analyzed, due to missing data.'}, {'title': 'BODE Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The BODE Index is comprised of a person\'s body mass index ("B"), airway obstruction ("O"), dyspnea ("D"), and exercise tolerance ("E"). Each of these components is graded on a scale of either 0 to 1 or 0 to 3. The final value-ranging from 0 to 10-provides doctors a percentage of how likely a person is to survive for four years. The final BODE tabulation is described as follows:\n\n0 to 2 points: 80 percent likelihood of survival 3 to 4 points: 67 percent likelihood of survival 5 of 6 points: 57 percent likelihood of survival 7 to 10 points: 18 percent likelihood of survival', 'unitOfMeasure': 'Index', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only 126 EBV subjects were analyzed, due to missing data.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-23', 'size': 4946573, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-06T17:35', 'hasProtocol': True}, {'date': '2017-10-26', 'size': 235796, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-06T12:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2013-02-20', 'resultsFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2013-02-20', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-08', 'studyFirstPostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1-second (FEV1)', 'timeFrame': '1 year', 'description': 'The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of \\>15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure.'}], 'secondaryOutcomes': [{'measure': 'FEV1 Post-bronchodilator Absolute Change', 'timeFrame': '1 year', 'description': 'Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ)", 'timeFrame': '1 year', 'description': "Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline).\n\nThe St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:\n\nPart I: Symptoms (frequency \\& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)\n\nA Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations."}, {'measure': '6-minute Walk Distance', 'timeFrame': '1 year', 'description': "Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['emphysema', 'endobronchial valve', 'treatments', 'pulmonary rehabilitation', 'lung volume reduction'], 'conditions': ['Emphysema']}, 'referencesModule': {'references': [{'pmid': '39515624', 'type': 'DERIVED', 'citation': 'Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.'}, {'pmid': '32223724', 'type': 'DERIVED', 'citation': 'Dransfield MT, Garner JL, Bhatt SP, Slebos DJ, Klooster K, Sciurba FC, Shah PL, Marchetti NT, Sue RD, Wright S, Rivas-Perez H, Wiese TA, Wahidi MM, Goulart de Oliveira H, Armstrong B, Radhakrishnan S, Shargill NS, Criner GJ; LIBERATE Study Group:. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial. Ann Am Thorac Soc. 2020 Jul;17(7):829-838. doi: 10.1513/AnnalsATS.201909-666OC.'}, {'pmid': '29787288', 'type': 'DERIVED', 'citation': 'Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.', 'detailedDescription': 'The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.\n\nThe LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the \'Treatment\' group or to the \'Control\' group. The \'Treatment\' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The \'Control\' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the \'Treatment\' group and one will go into the \'Control\' group.\n\nIt is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.\n\nBased on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve System was approved by the FDA for the treatment of severe emphysema in June 2018. Following this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5 years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under the auspices of the "LIBERATE Extension Study". This is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. All annual follow-up visits and evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the LIBERATE Extension Study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and radiological evidence of emphysema\n* Nonsmoking for 4 months prior to screening interview\n* BMI less than 35 kg/m2\n* Stable on current medication regimen\n* Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value\n* Residual Volume less than 175% predicted (determined by body plethysmography)\n* Little or no collateral ventilation (CV-) as determined using the Chartis System\n\nExclusion Criteria:\n\n* Had two or more hospitalizations over the last year for a COPD exacerbation\n* Had two or more hospitalizations over the last year for pneumonia\n* Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy\n* Had a heart attack or congestive heart failure within the last 6 months\n* Have heart arrhythmia\n* Is alpha-1 antitrypsin deficient'}, 'identificationModule': {'nctId': 'NCT01796392', 'acronym': 'LIBERATE', 'briefTitle': 'Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulmonx Corporation'}, 'officialTitle': 'Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema', 'orgStudyIdInfo': {'id': '600-0012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EBV and Optimal Medical Management', 'description': 'This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.', 'interventionNames': ['Device: EBV']}, {'type': 'OTHER', 'label': 'Optimal Medical Management', 'description': 'This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.', 'interventionNames': ['Other: Optimal Medical Management']}], 'interventions': [{'name': 'EBV', 'type': 'DEVICE', 'description': 'This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.', 'armGroupLabels': ['EBV and Optimal Medical Management']}, {'name': 'Optimal Medical Management', 'type': 'OTHER', 'description': 'This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.', 'armGroupLabels': ['Optimal Medical Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Pulmonary Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Hospital', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94507', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Research Foundation', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'INCOR - Hospital das Clinicas de Faculdade de Medicine da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '9700', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': 'BS2 8HW', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Infirmary', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital Llandough and University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton & Harefield NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gerard Criner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University Hospital, Philadelphia, PA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmonx Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}