Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02460120
Status:
TERMINATED
Last Update Posted:
2017-01-27
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Archimedes™ System for Transparenchymal Nodule Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-11-21', 'releaseDate': '2019-10-30'}], 'estimatedResultsFirstSubmitDate': '2019-10-30'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Updates to device', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of biopsies yielding tissue sufficient for diagnosis', 'timeFrame': 'Up to 1 year', 'description': 'The the number of nodules with at least one biopsy sufficient for a definitive tissue diagnosis divided by the number of nodules sampled by the Archimedes System.'}], 'secondaryOutcomes': [{'measure': 'Procedure planning time', 'timeFrame': 'Up to 1 year', 'description': 'The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported.'}, {'measure': 'Nodule access time', 'timeFrame': 'Up to 1 year', 'description': 'The time from the start of navigation until the sheath has been placed at the first biopsy target.'}, {'measure': 'Fluoroscopy time', 'timeFrame': 'Up to 1 year', 'description': 'The total fluoroscopy time from the start of fused-fluoroscopic navigational guidance to the time the devices are removed from the point of entry.'}, {'measure': 'Patient registration time', 'timeFrame': 'Up to 1 year', 'description': "The total time it takes to correlate the patient's position via fluoroscopy with the navigational guidance system."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': "The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 21-75 years at screening\n2. Highly suspicious SPN, defined as distinct nodule with a diameter of ≥8mm in its largest dimension\n3. No known endobronchial tumor\n4. Tumor located anywhere in parenchymal tissue \\>1 cm from pleura and accessible bronchoscopically through a POE.\n5. Willing to participate in all aspects of study protocol for duration of study\n6. Able to understand study requirements\n7. Signs study-related informed consent document\n\nExclusion Criteria:\n\n1. Any contraindication to bronchoscopy, for example:\n\n * Untreatable life-threatening arrhythmias\n * Inability to adequately oxygenate the patient during the procedure\n * Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)\n * Recent myocardial infarction\n * Previously diagnosed high-grade tracheal obstruction\n * Uncorrectable coagulopathy\n2. Known coagulopathy\n3. Platelet dysfunction or platelet count \\< 100 x 103 cells/mm3\n4. History of major bleeding with bronchoscopy\n5. Suspected pulmonary hypertension: additional testing required, such as echocardiogram\n6. Moderate-to-severe pulmonary fibrosis\n7. Severe emphysema or COPD: additional testing and PI consent is required\n8. Bullae \\>5 cm located in vicinity of target SPN\n9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:\n\n * ASA class \\> 3\n * \\> stage 3 heart failure\n * severe cachexia\n * severe respiratory insufficiency or hypoxia\n10. Ongoing systemic infection\n11. Contraindication to general anesthesia\n12. Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure\n13. Participation in any other study in last 30 days\n14. Prior thoracic surgery on the same side of the lung as the SPN.\n15. Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.\n16. Life expectancy of less than one year.\n17. Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy\n18. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02460120', 'acronym': 'EAST', 'briefTitle': 'Evaluation of the Archimedes™ System for Transparenchymal Nodule Access', 'organization': {'class': 'INDUSTRY', 'fullName': 'Broncus Medical Inc'}, 'officialTitle': 'Evaluation of the Archimedes™ System for Transparenchymal Nodule Access', 'orgStudyIdInfo': {'id': 'Protocol 43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigation and tissue sampling', 'description': 'Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System', 'interventionNames': ['Device: Archimedes System']}], 'interventions': [{'name': 'Archimedes System', 'type': 'DEVICE', 'description': 'The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs', 'armGroupLabels': ['Navigation and tissue sampling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74133', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Treatment Centers of America at Southwestern Regional Medical Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Daniel Nader, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Treatment Centers of America at Southwestern Regional Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Broncus Medical Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-10-30', 'type': 'RELEASE'}, {'date': '2019-11-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Broncus Medical Inc'}}}}