Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT03623958
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2018-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Guided VATS vs. VATS Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D020775', 'term': 'Thoracic Surgery, Video-Assisted'}], 'ancestors': [{'id': 'D013906', 'term': 'Thoracoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D020535', 'term': 'Video-Assisted Surgery'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quantitative Analysis of CT scans', 'timeFrame': '3 years', 'description': 'To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm.'}], 'primaryOutcomes': [{'measure': 'Operating Room Time', 'timeFrame': '3 years to complete', 'description': 'The time (in min.) from incision to close'}], 'secondaryOutcomes': [{'measure': 'Time to T-bar placement', 'timeFrame': '3 years', 'description': 'The time from patient ready for surgery to placement of t-bar'}, {'measure': 'Time for induction to incision', 'timeFrame': '3 years', 'description': 'Time (in min) from induction to incision made'}, {'measure': 'Hospital Length of Stay', 'timeFrame': '3 years', 'description': 'Length of hospital stay (in days) in both arms'}, {'measure': 'Radiation Exposure', 'timeFrame': '3 years', 'description': 'The radiation exposure (mSV) in the iVATS arm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['image guided', 'lung nodule', 'lung cancer', 'lung mass'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '26031893', 'type': 'RESULT', 'citation': 'Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.', 'detailedDescription': 'This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be 18 years and older\n* Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon\n* Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm\n* Subject's lesions that are located in the outer half portion of the lung/lobe.\n* Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics\n\nExclusion Criteria:\n\n* If participant is a pregnant woman or breast feeding they will not be eligible.\n* If treating thoracic surgeon deems the participant not eligible for the study."}, 'identificationModule': {'nctId': 'NCT03623958', 'briefTitle': 'Image Guided VATS vs. VATS Resection', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Image Guided VATS Resection vs. VATS Resection of Lung Lesions', 'orgStudyIdInfo': {'id': '2017P000291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iVATS resection', 'description': 'Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.', 'interventionNames': ['Device: Image guided Video-Assisted Thoracic Surgery (VATS) resection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard VATS resection', 'description': 'Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.', 'interventionNames': ['Procedure: Video-Assisted Thoracic Surgery']}], 'interventions': [{'name': 'Image guided Video-Assisted Thoracic Surgery (VATS) resection', 'type': 'DEVICE', 'description': 'Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed', 'armGroupLabels': ['iVATS resection']}, {'name': 'Video-Assisted Thoracic Surgery', 'type': 'PROCEDURE', 'description': 'Standard of Care Video-Assisted Thoracic Surgery (VATS) resection', 'armGroupLabels': ['Standard VATS resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raphael Bueno, MD', 'role': 'CONTACT', 'email': 'rbueno@bwh.harvard.edu', 'phone': '617-732-5004'}, {'name': 'Julianne Barlow', 'role': 'CONTACT', 'email': 'jbarlow1@bwh.harvard.edu', 'phone': '617-525-8704'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Julianne S Barlow', 'role': 'CONTACT', 'email': 'jbarlow1@bwh.harvard.edu', 'phone': '617-525-8704'}], 'overallOfficials': [{'name': 'Raphael Bueno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Throacic Surgery', 'investigatorFullName': 'Raphael Bueno', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}