Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-07 @ 6:02 AM
Study NCT ID:
NCT03585959
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2018-06-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'katie.j.bayliss@medtronic.com', 'phone': '(763) 647-5547', 'title': 'Katie Bayliss', 'organization': 'Medtronic'}, 'certainAgreement': {'otherDetails': "Institution/Investigator may publish the results of work performed under this Agreement, in accordance with the Publication Policy described in the Clinical Investigation Plan and publication guidelines from the Declaration of Helsinki. Institution and Investigator shall not publish the Study results until after Medtronic's Multi-site publication or until the elapse of twelve (12) months from the close of the Study at all Study sites, whichever occurs first.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events will be collected after the ENB index procedure has been initiated (defined as introduction of the locatable guide or extended working channel into the subject). Adverse events will be collected immediately post procedure and at 7-day post procedure visit, with a window of 4-7 days post-procedure.', 'description': 'An Adverse Event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.\n\nThis definition includes events related to:\n\n1. the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology and all superDimension™ tools and accessories.\n2. the procedures involved, including bronchoscopy and sedation.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 7, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Haemoptysis', 'notes': 'Coughing up blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pneumothorax', 'notes': 'Tiny left apical pneumothorax noted on post-bronchoscopic x-ray', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dizziness', 'notes': 'Patient feeling lightheaded, but it was relieved with rest.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary Retention', 'notes': 'Difficulty urinating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'notes': 'Chronic obstructive pulmonary disease (COPD) Exacerbation, shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Infection', 'notes': 'VIRAL ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirm the Location Accuracy of the Local Registration Feature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.'}], 'classes': [{'title': 'All Technically Successful Cases, FNAV/CBCT 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Target overlap achieved', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Target overlap not achieved', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'All Technically Successful Cases, FNAV/CBCT 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Target overlap achieved', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Target overlap not achieved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'All Evaluable Cases, FNAV/CBCT 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Target overlap achieved', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Target overlap not achieved', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'All Evaluable Cases, FNAV/CBCT 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Target overlap achieved', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Target overlap not achieved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of procedure', 'description': 'The Primary Endpoint is the measured ability of the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology to place the center of the virtual navigation target (green ball) on the intended target lesion as confirmed by cone-beam computed tomography (CBCT).\n\nThe primary endpoint was evaluated in technically successful cases (those with local registration complete) and calculated as the percentage of cases in which the virtual target was correctly placed to overlap the target lesion, as confirmed by CBCT. The percent overlap was calculated in three dimensions (X, Y, and Z coordinates). Any case with more than 0% overlap was considered a primary endpoint success.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group."}, {'type': 'SECONDARY', 'title': 'Number of Cases That Are Technically Successful (Successful Completion of Local Registration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of procedure', 'description': 'Technical success was defined as successful completion of local registration utilizing fluoroscopic navigation technology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Cases That Are Not Technically Successful (Local Registration Not Complete)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of procedure', 'description': 'By device design, if the local registration algorithm determines that the correction distance is greater than 3.0 cm the location of the virtual target will not be updated. These cases are not considered technically successful according to the clinical study definitions, even though the device performed as designed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 of 49 cases did not complete local registration'}, {'type': 'SECONDARY', 'title': 'Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of procedure', 'description': 'Investigator confirmation that the catheter was in an "adequate periprocedural location" (the location of the extended working channel when the proceduralist made the decision that placement was adequate and clinically acceptable to proceed with tissue sampling). Adequate periprocedural location is reported with use of local registration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '22.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of procedure', 'description': 'Total time from the first entry of the bronchoscope to the final removal of the bronchoscope. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ENB Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '20.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of procedure', 'description': 'ENB procedure time captured in the electronic data capture database being utilized for the study defined as the total time from the first entry of the extended working channel or locatable guide until the last exit of the extended working channel. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}, {'units': 'Local Registrations', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '7.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day of procedure', 'description': 'Total fluoroscopy time captured in the electronic data capture database being utilized for the study was determined to not be clinically relevant. Instead, the fluoroscopic navigation time is presented. Fluoroscopic Navigation Time: Two sweeps pooled. Encompasses c-arm sweep, target marking, and algorithm computational time, inclusive of the initiation of the local registration applet to the time the updated catheter location was ready and on screen (not including CBCT), as measured by the system software', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Local Registrations', 'denomUnitsSelected': 'Local Registrations', 'populationDescription': 'Four cases were considered technically successful but could not be analyzed due to inadequate video recording and an additional four technically successful cases had data from only FNAV/CBCT 1 (n=2) or only FNAV/CBCT 2 (n=2), resulting in evaluable datasets of 41 subjects per FNAV/CBCT group.'}, {'type': 'SECONDARY', 'title': 'Adequacy of the ENB-aided Tissue Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Based on final pathology results of the ENB-aided biopsy sample collected day of procedure', 'description': 'Adequacy of the ENB-aided tissue sample for rapid on-site evaluation (ROSE) of cytologic samples by pathology (when applicable). This will be captured in the electronic data capture database.ROSE results could be reported as "Benign", "Inconclusive", "Malignant", "Inadequate Tissue for ROSE", or "N/A". If all ROSE diagnoses were report as "Inadequate Tissue for ROSE", for a participant, then the case was considered as "Inadequate Tissue".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ROSE was attempted in 49/49 cases.'}, {'type': 'SECONDARY', 'title': 'Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'title': 'Malignant', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Other', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of procedure', 'description': 'Histopathological call based on ROSE of the ENB-aided tissue sample (when applicable) captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Final Pathology Results of the ENB-aided Tissue Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'title': 'Malignant', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Other', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Based on final pathology results of the ENB-aided biopsy sample collected day of procedure', 'description': 'Final pathology results of the ENB-aided tissue sample captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biopsy Tools Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'title': 'Aspiration Needle', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Biopsy Forceps', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'GenCut Core Biopsy Tool', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Cytology Brush', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'superDimension triple needle cytology brush', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'superDimension needle-tipped cytology brush', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Bronchoalveolar lavage/washing', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day of procedure', 'description': 'Biopsy tools used was captured in the electronic data capture database being utilized for the study on all subjects with local registration attempted. If subject use same tool more than once, only counts once.', 'unitOfMeasure': 'tool use', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tool Order', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'title': 'Aspirating needle', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Cytology brush', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of procedure', 'description': 'Tool order analysis reports the number of times that a tool was used first in a patient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Tool Pases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'title': 'Arcpoint pulmonary needle', 'categories': [{'measurements': [{'value': '6', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': 'Aspirating needle, superDimension', 'categories': [{'measurements': [{'value': '9', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Cytology brush, non-superDimension', 'categories': [{'measurements': [{'value': '2', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cytology brush, superDimension', 'categories': [{'measurements': [{'value': '4', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of procedure', 'description': "An analysis of the number of passes for each tool was planned, but it was determined that it wouldn't be clinically meaningful to go into that level of detail for the analysis and instead focused on the number of passes for only the first tool used.", 'unitOfMeasure': 'passes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'title': 'Aspirating Needle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Biopsy Forcep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cytology Brush', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'superDimension Needle-Tipped Cytology Brush', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Gencut Core Biopsy Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'superDimension Triple Needle Cytology Brush', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Based on ROSE results of the ENB-aided biopsy sample collected day of procedure', 'description': 'The "tool-specific accuracy for malignancy" is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with overall malignant results by ROSE (26/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case. Bronchoalveolar Lavage is not applicable for ROSE.'}, {'type': 'SECONDARY', 'title': 'Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluorscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.'}], 'classes': [{'title': 'Aspirating Needle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Biopsy Forceps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Cytology Brush', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'superDimension Needle-Tipped Cytology Brush', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Gencut Core Biopsy Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'superDimension Triple Needle cytology Brush', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bronchoalveolar Lavage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Based on final pathology results of the ENB-aided sample collected day of procedure', 'description': 'The "tool-specific accuracy for malignancy" is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design.', 'unitOfMeasure': 'malignant results', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with overall malignant results by Pathology (30/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case.'}, {'type': 'SECONDARY', 'title': 'Percentage of Cases in Which the Intended Lesion is Correctly Identified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'categories': [{'title': 'correct identification of intended lesion', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'incorrect identification of intended lesion', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day of procedure', 'description': 'In technically successful cases (local registration complete) the percentage of cases in which the intended lesion is correctly identified (as opposed to a non-target lesion or normal lung tissue) as indicated by the system software.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '38 subjects had adequate video files to assess this endpoint'}, {'type': 'SECONDARY', 'title': 'Relational Accuracy in Cases in Which the Intended Lesion is Targeted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.\n\nsuperDimension™ Navigation System Version 7.2: superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy'}], 'classes': [{'title': 'Relational accuracy, Before location correction', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '97.0'}]}]}, {'title': 'Relational accuracy, after location correction', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day of procedure', 'description': 'In Technically successful cases (local registration complete) with evaluable videos the relational accuracy in cases in which the intended lesion is targeted was assessed. Relational accuracy is defined as the three-dimensional percentage overlap between the virtual target and the actual lesion in CBCT before (FNAV/CBCT 1) and after (FNAV/CBCT 2) correction of the catheter location.', 'unitOfMeasure': '3D percent overlap', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.'}], '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': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unsuccessful Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.8', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Black of African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medical History', 'classes': [{'title': 'Chronic Obstructive Pulmonary Disease (COPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Tobacco Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lesion Characteristics', 'classes': [{'title': 'Lesion < 20 mm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Upper Lobe Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Pure to mostly solid (Suzuki Class 5 or 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'Bronchus Sign Present on CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'lesion', 'populationDescription': 'Lesion data is only available in subjects with local registration attempted.'}], 'populationDescription': 'All enrolled subjects were underwent baseline analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-09', 'size': 734068, 'label': 'Study Protocol: Clinical Investigation Plan', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-05T17:51', 'hasProtocol': True}, {'date': '2019-05-21', 'size': 462941, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-05T18:01', 'hasProtocol': False}, {'date': '2019-12-05', 'size': 417265, 'label': 'Study Protocol: Clinical Investigation Plan Note to File', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-05T18:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2018-06-21', 'resultsFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-24', 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirm the Location Accuracy of the Local Registration Feature', 'timeFrame': 'day of procedure', 'description': 'The Primary Endpoint is the measured ability of the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology to place the center of the virtual navigation target (green ball) on the intended target lesion as confirmed by cone-beam computed tomography (CBCT).\n\nThe primary endpoint was evaluated in technically successful cases (those with local registration complete) and calculated as the percentage of cases in which the virtual target was correctly placed to overlap the target lesion, as confirmed by CBCT. The percent overlap was calculated in three dimensions (X, Y, and Z coordinates). Any case with more than 0% overlap was considered a primary endpoint success.'}], 'secondaryOutcomes': [{'measure': 'Number of Cases That Are Technically Successful (Successful Completion of Local Registration)', 'timeFrame': 'day of procedure', 'description': 'Technical success was defined as successful completion of local registration utilizing fluoroscopic navigation technology.'}, {'measure': 'Number of Cases That Are Not Technically Successful (Local Registration Not Complete)', 'timeFrame': 'day of procedure', 'description': 'By device design, if the local registration algorithm determines that the correction distance is greater than 3.0 cm the location of the virtual target will not be updated. These cases are not considered technically successful according to the clinical study definitions, even though the device performed as designed.'}, {'measure': 'Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.', 'timeFrame': 'day of procedure', 'description': 'Investigator confirmation that the catheter was in an "adequate periprocedural location" (the location of the extended working channel when the proceduralist made the decision that placement was adequate and clinically acceptable to proceed with tissue sampling). Adequate periprocedural location is reported with use of local registration.'}, {'measure': 'Total Procedure Time', 'timeFrame': 'day of procedure', 'description': 'Total time from the first entry of the bronchoscope to the final removal of the bronchoscope. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice'}, {'measure': 'ENB Procedure Time', 'timeFrame': 'day of procedure', 'description': 'ENB procedure time captured in the electronic data capture database being utilized for the study defined as the total time from the first entry of the extended working channel or locatable guide until the last exit of the extended working channel. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice'}, {'measure': 'Total Fluoroscopy Time', 'timeFrame': 'day of procedure', 'description': 'Total fluoroscopy time captured in the electronic data capture database being utilized for the study was determined to not be clinically relevant. Instead, the fluoroscopic navigation time is presented. Fluoroscopic Navigation Time: Two sweeps pooled. Encompasses c-arm sweep, target marking, and algorithm computational time, inclusive of the initiation of the local registration applet to the time the updated catheter location was ready and on screen (not including CBCT), as measured by the system software'}, {'measure': 'Adequacy of the ENB-aided Tissue Sample', 'timeFrame': 'Based on final pathology results of the ENB-aided biopsy sample collected day of procedure', 'description': 'Adequacy of the ENB-aided tissue sample for rapid on-site evaluation (ROSE) of cytologic samples by pathology (when applicable). This will be captured in the electronic data capture database.ROSE results could be reported as "Benign", "Inconclusive", "Malignant", "Inadequate Tissue for ROSE", or "N/A". If all ROSE diagnoses were report as "Inadequate Tissue for ROSE", for a participant, then the case was considered as "Inadequate Tissue".'}, {'measure': 'Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable)', 'timeFrame': 'day of procedure', 'description': 'Histopathological call based on ROSE of the ENB-aided tissue sample (when applicable) captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.'}, {'measure': 'Final Pathology Results of the ENB-aided Tissue Sample', 'timeFrame': 'Based on final pathology results of the ENB-aided biopsy sample collected day of procedure', 'description': 'Final pathology results of the ENB-aided tissue sample captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.'}, {'measure': 'Biopsy Tools Used', 'timeFrame': 'day of procedure', 'description': 'Biopsy tools used was captured in the electronic data capture database being utilized for the study on all subjects with local registration attempted. If subject use same tool more than once, only counts once.'}, {'measure': 'Tool Order', 'timeFrame': 'day of procedure', 'description': 'Tool order analysis reports the number of times that a tool was used first in a patient.'}, {'measure': 'Number of Tool Pases', 'timeFrame': 'day of procedure', 'description': "An analysis of the number of passes for each tool was planned, but it was determined that it wouldn't be clinically meaningful to go into that level of detail for the analysis and instead focused on the number of passes for only the first tool used."}, {'measure': 'Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample', 'timeFrame': 'Based on ROSE results of the ENB-aided biopsy sample collected day of procedure', 'description': 'The "tool-specific accuracy for malignancy" is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design.'}, {'measure': 'Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample', 'timeFrame': 'Based on final pathology results of the ENB-aided sample collected day of procedure', 'description': 'The "tool-specific accuracy for malignancy" is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design.'}, {'measure': 'Percentage of Cases in Which the Intended Lesion is Correctly Identified', 'timeFrame': 'day of procedure', 'description': 'In technically successful cases (local registration complete) the percentage of cases in which the intended lesion is correctly identified (as opposed to a non-target lesion or normal lung tissue) as indicated by the system software.'}, {'measure': 'Relational Accuracy in Cases in Which the Intended Lesion is Targeted', 'timeFrame': 'day of procedure', 'description': 'In Technically successful cases (local registration complete) with evaluable videos the relational accuracy in cases in which the intended lesion is targeted was assessed. Relational accuracy is defined as the three-dimensional percentage overlap between the virtual target and the actual lesion in CBCT before (FNAV/CBCT 1) and after (FNAV/CBCT 2) correction of the catheter location.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.', 'detailedDescription': 'The primary objective of this post-market feasibility study is to confirm the location accuracy of the local registration feature of the superDimension™ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation\n2. Lesion is intended to be biopsied by the participating investigator\n3. Subject is willing and able to provide informed consent to participate in the study\n4. Subject is a candidate for an elective ENB procedure\n5. Subject is over the age of 18\n\nExclusion Criteria:\n\n1. Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB\n2. Lesions within 10 mm of the diaphragm\n3. The subject is unable or unwilling to comply with study follow-up schedule\n4. The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study\n5. Female subjects who are pregnant or nursing as determined by standard site practices'}, 'identificationModule': {'nctId': 'NCT03585959', 'briefTitle': 'superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'A Post-market Feasibility Study Evaluating Location Accuracy Using the superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology in Subjects Undergoing Lung Lesion Biopsy', 'orgStudyIdInfo': {'id': 'MDT18004ILSFNV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoroscopic Navigation Arm', 'description': 'An Electromagnetic navigation bronchoscopy (ENB) system which provides enhanced three-dimensional fluoroscopy to improve lesion visibility and to compensate for CT-to-body divergence, with an integrated real-time local registration feature allowing the operator to update the catheter position relative to the target during the procedure.', 'interventionNames': ['Device: superDimension™ Navigation System Version 7.2']}], 'interventions': [{'name': 'superDimension™ Navigation System Version 7.2', 'type': 'DEVICE', 'description': 'superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy', 'armGroupLabels': ['Fluoroscopic Navigation Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'FirstHealth Moore Regional Hospital', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'CHI Memorial Medical Group', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}], 'overallOfficials': [{'name': 'Michael A. Pritchett, DO MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FirstHealth Moore Regional Hospital'}, {'name': 'Krishnendu Bhadra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHI Memorial Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}