Viewing Study NCT00562302

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Ignite Creation Date: 2025-12-25 @ 4:01 AM
Ignite Modification Date: 2026-01-29 @ 1:59 AM
Study NCT ID: NCT00562302
Status: COMPLETED
Last Update Posted: 2013-03-27
First Post: 2007-11-20
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tdoyle@angio.com', 'phone': '352.338.0440', 'title': 'Thomas Doyle', 'organization': 'Angiotech'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted', 'otherNumAtRisk': 170, 'otherNumAffected': 60, 'seriousNumAtRisk': 170, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Control group with no intervention', 'otherNumAtRisk': 169, 'otherNumAffected': 90, 'seriousNumAtRisk': 169, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ADVERSE DRUG REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ENERGY INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INFUSION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PUNCTURE SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CLAVICLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HAEMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INCISION SITE COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PNEUMOTHORAX TRAUMATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VULVOVAGINAL MYCOTIC INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'LUNG NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MALIGNANT NEOPLASM PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MALIGNANT PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CACHEXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MENTAL STATUS CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PULMONARY HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PULMONARY GRANULOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SUPERIOR VENA CAVAL OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Allergic reaction to anesthesia/drugs', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Bleeding at puncture site', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Emphysema (subcutaneous)', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Hemoptysis', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Pneumothorax', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 53, 'numAffected': 53}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Pleural fluid', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Chest pain with pneumothorax', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Chest pain without pneumothorax', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Puncture site bruising', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Fatigue', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Coughing with Blood', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}, {'term': 'Altered lung function', 'notes': 'Anticipated Adverse Device Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Protocol'}], 'seriousEvents': [{'term': 'PULMONARY HEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal 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[{'value': '6', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'A chest tube is the definitive initial treatment of a pneumothorax.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat Population'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '6.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Incidence of Hospital Admissions for Pneumothorax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat Population'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events Related to the Procedure and Device Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Day', 'description': 'Anticipated, device-related adverse events that were defined in the original protocol.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Patients'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Additional Chest X-rays Needed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 day', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': "Participants Discharged Beyond Hospital's Standard of Care", 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30-day', 'description': "Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital's standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Any treatment emergent adverse events (not considered device related by the investigators).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lung resection prior to study completion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Not stated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Control group with no intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '11.47', 'groupId': 'BG000'}, {'value': '67.2', 'spread': '12.38', 'groupId': 'BG001'}, {'value': '66.7', 'spread': '11.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Smoking', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 339}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'dispFirstSubmitDate': '2010-11-19', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-26', 'studyFirstSubmitDate': '2007-11-20', 'dispFirstSubmitQcDate': '2010-11-19', 'resultsFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2007-11-20', 'dispFirstPostDateStruct': {'date': '2010-11-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-26', 'studyFirstPostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Treatment Success', 'timeFrame': '30 days', 'description': 'Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Chest Tube Placement', 'timeFrame': '30 days', 'description': 'A chest tube is the definitive initial treatment of a pneumothorax.'}, {'measure': 'Time to Ambulation', 'timeFrame': '30 days'}, {'measure': 'Incidence of Hospital Admissions for Pneumothorax', 'timeFrame': '30 day'}, {'measure': 'Incidence of Adverse Events Related to the Procedure and Device Effects', 'timeFrame': '30 Day', 'description': 'Anticipated, device-related adverse events that were defined in the original protocol.'}, {'measure': 'Number of Participants With Additional Chest X-rays Needed', 'timeFrame': '30 day'}, {'measure': "Participants Discharged Beyond Hospital's Standard of Care", 'timeFrame': '30-day', 'description': "Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital's standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care."}, {'measure': 'Incidence of Adverse Events', 'timeFrame': '30 days', 'description': 'Any treatment emergent adverse events (not considered device related by the investigators).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung biopsy'], 'conditions': ['Pneumothorax']}, 'descriptionModule': {'briefSummary': 'BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures', 'detailedDescription': 'This is a multi-centered, randomized trial in patients receiving lung biopsies. Patients will be randomized to either receive or not receive a Bio-Seal Biopsy Track Plug after a lung biopsy per standard hospital protocol. This study is designed to demonstrate safety and efficacy of the Bio-Seal Biopsy Track Plug in reducing pneumothorax rates post lung biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must meet all medical conditions for lung biopsy;\n* The patient must be at least 18 years of age;\n* The patient, or legal representative, must understand and provide written consent for the procedure;\n* The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.\n\nExclusion Criteria:\n\n* Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;\n* Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;\n* Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.\n* Patients who are uncooperative or cannot follow instructions.\n* Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.'}, 'identificationModule': {'nctId': 'NCT00562302', 'briefTitle': 'Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiotech Pharmaceuticals'}, 'officialTitle': 'A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy', 'orgStudyIdInfo': {'id': 'BS-1053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bio-Seal Group', 'description': 'Bio-Seal Plug Implanted', 'interventionNames': ['Device: Bio-Seal Plug']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group with no intervention'}], 'interventions': [{'name': 'Bio-Seal Plug', 'type': 'DEVICE', 'otherNames': ['Bio-Seal™ Lung Biopsy Tract System'], 'description': 'Deployment of the Bio-Seal plug in needle track', 'armGroupLabels': ['Bio-Seal Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Medical Imaging', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85711', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'St. Josephs Radiology Limited'}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Univerisity of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '208042', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Vascular and Interventional Radiology', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Morton Plant Mease Health Care', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Research Network', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45287', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univeristy of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'St Lukes Hospital', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '15905', 'city': 'Johnstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 40.32674, 'lon': -78.92197}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Memorial Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas/MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Healthcare Diagnostic Imaging', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Sacred Heart Medical Center & Heart Institute of Spokane', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Rui Avelar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Angiotech Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angiotech Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}