Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-03-03 @ 2:33 AM
Study NCT ID:
NCT03056300
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
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'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This was a single arm study with a limited sample size.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.', 'eventGroups': [{'id': 'EG000', 'title': 'Powered Vascular Stapler', 'description': 'All enrolled subjects who had surgery performed using the powered vascular stapler.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 12, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary air leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Intra-Operative Hemostatic Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'Vessel Transections', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Powered Vascular Stapler', 'description': 'All enrolled subjects who had surgery performed using the powered vascular stapler.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Intra-Operative', 'description': 'Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).', 'unitOfMeasure': 'Percentage of vessel transections', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Vessel Transections', 'denomUnitsSelected': 'Vessel Transections', 'populationDescription': 'All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions'}, {'type': 'PRIMARY', 'title': 'Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Powered Vascular Stapler', 'description': 'All enrolled subjects who had surgery performed using the powered vascular stapler.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-op through 4 week follow-up', 'description': 'Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS:\n\n* Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).\n\nNo hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects in whom a procedure was started.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Powered Vascular Stapler', 'description': 'All enrolled subjects who had surgery performed using the powered vascular stapler.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Surgical reason per study protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment occurred from January 2017 to April 2017 across 4 sites.', 'preAssignmentDetails': 'This was a single-arm study where all enrolled patients would have their surgery performed using the powered vascular stapler.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Powered Vascular Stapler', 'description': 'All enrolled subjects who had surgery performed using the powered vascular stapler.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.'}], 'populationDescription': 'All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-11', 'size': 18953153, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-01T10:58', 'hasProtocol': True}, {'date': '2017-07-06', 'size': 808262, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-01T10:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2017-01-26', 'resultsFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2017-02-14', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-01', 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Intra-Operative Hemostatic Interventions', 'timeFrame': 'Intra-Operative', 'description': 'Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).'}, {'measure': 'Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding', 'timeFrame': 'Post-op through 4 week follow-up', 'description': 'Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS:\n\n* Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).\n\nNo hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;\n2. Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;\n3. Performance status 0-1 (Eastern Cooperative Oncology Group classification);\n4. ASA score \\< 3;\n5. No prior history of VATS or open lung surgery (on the lung in which the procedure will be performed);\n6. Willing to give consent and comply with study-related evaluation and treatment schedule; and\n7. 18-75 years of age (inclusive).\n\nExclusion Criteria:\n\n1. Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;\n2. Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);\n3. Uncontrolled diabetes mellitus;\n4. End stage renal or liver disease;\n5. History of severe cardiovascular disease;\n6. FEV1% \\<50% or severe COPD;\n7. Prior chemotherapy or radiation for lung cancer;\n8. Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);\n9. Robotic-assisted procedure;\n10. Women who are pregnant or lactating at the time of screening;\n11. Physical or psychological condition which would impair study participation;\n12. The subject is judged unsuitable for study participation by the Investigator for any other reason;\n13. Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or\n14. Unable or unwilling to attend follow-up visits and examinations."}, 'identificationModule': {'nctId': 'NCT03056300', 'briefTitle': 'A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'orgStudyIdInfo': {'id': 'ESC-14-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Powered vascular stapler', 'description': 'Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler', 'interventionNames': ['Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler']}], 'interventions': [{'name': 'Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler', 'type': 'DEVICE', 'description': 'Powered Vascular Stapler used on vessels', 'armGroupLabels': ['Powered vascular stapler']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Keneng Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}, {'name': 'Shugeng Gao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Services'}, {'name': 'Hu Jian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The first affiliated hospital Zhejiang University/Hangzhou'}, {'name': 'Li Jian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship hospital/Hangzhou'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}