Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 7:00 PM
Study NCT ID:
NCT00912366
Status:
TERMINATED
Last Update Posted:
2015-07-27
First Post:
2009-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038481', 'term': 'Anterior Temporal Lobectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Slow Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-23', 'studyFirstSubmitDate': '2009-06-01', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess hospital length of stay (LOS).', 'timeFrame': '1 time point (discharge)'}, {'measure': 'Pain Scale Evaluation', 'timeFrame': '5 time points out to 6 months'}], 'secondaryOutcomes': [{'measure': 'Assess quality of life.', 'timeFrame': '2 time points out to 6 months'}, {'measure': 'Assess peri-operative and post-operative complications.', 'timeFrame': '5 time points out to 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VATS', 'Lung cancer', 'NSCLC'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects referred for lobectomies at the hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be 18 years of age or older.\n* Subject must have been clinically diagnosed with stage I to stage IIA non small cell lung cancer measuring and judged to be resectable.\n* Subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy\n\nExclusion Criteria:\n\n* Subject is pregnant (documented by pregnancy test) or breastfeeding.\n* Subject has other severe illnesses that would preclude surgery such as\n\n * Unstable angina\n * Myocardial Infarction within 3 months\n * Coronary Artery Bypass Graft Surgery\n* Subject has other active cancers\n* Subject is unable to comply with any of the following:\n\n * Study requirements\n * Give valid informed consent\n * Follow-up schedule'}, 'identificationModule': {'nctId': 'NCT00912366', 'briefTitle': 'Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'A Prospective, Single Center, Observational Study Comparing the Safety and Efficacy of CVATS, HVATS and Open Surgery for Subjects Diagnosed With NSCLC Scheduled to Undergo a Lobectomy', 'orgStudyIdInfo': {'id': 'AS08015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'VATS', 'interventionNames': ['Procedure: Lobectomy']}, {'label': 'Group B', 'description': 'Open Surgery', 'interventionNames': ['Procedure: Lobectomy']}], 'interventions': [{'name': 'Lobectomy', 'type': 'PROCEDURE', 'otherNames': ['CVATS', 'HVATS'], 'description': 'Assessment of VATS versus open surgery.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}