Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-27 @ 12:43 PM
Study NCT ID:
NCT01843192
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2013-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Powered Echelon Device in VATS Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mschwier@its.jnj.com', 'phone': '513-337-1172', 'title': 'Michael Schwiers', 'organization': 'Ethicon, part of Johnson & Johnson'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of follow-up was scheduled through approximately 4 weeks post surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection', 'otherNumAtRisk': 26, 'otherNumAffected': 8, 'seriousNumAtRisk': 26, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy', 'otherNumAtRisk': 34, 'otherNumAffected': 6, 'seriousNumAtRisk': 34, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy', 'otherNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vascular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary air leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Postoperative Air Leaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '67.2'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '84.1'}, {'value': '88.9', 'groupId': 'OG002', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}, {'type': 'PRIMARY', 'title': 'Occurrence of Prolonged Air Leaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '21.1'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '23.5'}, {'value': '22.2', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '60'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}, {'type': 'SECONDARY', 'title': 'Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '1.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Determined as the length of time in days from hospital admission to initial hospital discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}, {'type': 'SECONDARY', 'title': 'Volume of Estimated Intra-operative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '56.48', 'groupId': 'OG000'}, {'value': '83.2', 'spread': '62.42', 'groupId': 'OG001'}, {'value': '86.1', 'spread': '80.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood loss intra-op and up to 5 days post-op', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}, {'type': 'SECONDARY', 'title': 'Time to Chest Tube Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '1.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of surgery', 'description': 'Defined as the duration in hours from the first skin incision to the closure of the last incision', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}, {'type': 'SECONDARY', 'title': 'Occurrence of Intra-operative Leak Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During surgery', 'description': 'This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure. This analysis was further restricted to those subjects in whom an intra-operative leak test was actually performed, as it was not standard of care at all participating institutions.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With 1 Chest Tube Placed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'OG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'OG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '88.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During surgery', 'description': 'All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'FG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'FG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Intra-operative exclusions per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "Individuals undergoing VATS lobectomy for suspected or confirmed Non-small Cell Lung Cancer, or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of Care, and who meet study entry criteria, were enrolled in this study.", 'preAssignmentDetails': 'There was no assignment to treatment group given that this is a single arm study wherein the same device was used on all subjects. Results are presented for the overall cohort as well as by the individual procedure performed - lobectomy, wedge resection, or wedge resection with lobectomy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Wedge Resection', 'description': 'Subjects undergoing VATS wedge resection'}, {'id': 'BG001', 'title': 'Lobectomy', 'description': 'Subjects undergoing VATS lobectomy'}, {'id': 'BG002', 'title': 'Wedge Resection With Lobectomy', 'description': 'Subjects undergoing VATS wedge resection that also required lobectomy'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '10.02', 'groupId': 'BG000'}, {'value': '68.1', 'spread': '7.26', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '5.72', 'groupId': 'BG002'}, {'value': '66.3', 'spread': '8.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2013-04-19', 'resultsFirstSubmitDate': '2015-03-06', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-06', 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Postoperative Air Leaks', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).'}, {'measure': 'Occurrence of Prolonged Air Leaks', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (LOS)', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Determined as the length of time in days from hospital admission to initial hospital discharge'}, {'measure': 'Volume of Estimated Intra-operative Blood Loss', 'timeFrame': 'Blood loss intra-op and up to 5 days post-op'}, {'measure': 'Time to Chest Tube Removal', 'timeFrame': 'Post-operative period through hospital discharge and follow-up at Day 30', 'description': 'Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.'}, {'measure': 'Operative Time', 'timeFrame': 'Day of surgery', 'description': 'Defined as the duration in hours from the first skin incision to the closure of the last incision'}, {'measure': 'Occurrence of Intra-operative Leak Test', 'timeFrame': 'During surgery', 'description': 'This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.'}, {'measure': 'Number of Subjects With 1 Chest Tube Placed', 'timeFrame': 'During surgery', 'description': 'All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Individuals with suspected or confirmed NSCLC, scheduled for VATS lobectomy or wedge resection in accordance with their institution's SOC", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected or confirmed NSCLC (up to and including Stage II)\n* Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung\n* Performance status 0-1 (Eastern Cooperative Oncology Group classification)\n* ASA score \\< 3\n* No prior history of VATS or open lung surgery\n* Willing to give consent and comply with study-related evaluation and treatment schedule\n\nExclusion Criteria:\n\n* Active bacterial infection or fungal infection;\n* Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)\n* Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure\n* Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)\n* Pregnancy\n* Physical or psychological condition which would impair study participation;\n* The patient is judged unsuitable for study participation by the Investigator for any other reason; or\n* Unable or unwilling to attend follow-up visits and examinations'}, 'identificationModule': {'nctId': 'NCT01843192', 'briefTitle': 'Powered Echelon Device in VATS Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon Endo-Surgery'}, 'officialTitle': 'A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures', 'orgStudyIdInfo': {'id': 'ESC-12-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VATS for suspected or confirmed NSCLC', 'description': 'Single arm study', 'interventionNames': ['Device: Endocutter']}], 'interventions': [{'name': 'Endocutter', 'type': 'DEVICE', 'armGroupLabels': ['VATS for suspected or confirmed NSCLC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Dignity Health, St. Joseph's Hospital & Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}