Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-10 @ 1:34 PM
Study NCT ID:
NCT03745859
Status:
TERMINATED
Last Update Posted:
2025-06-25
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New Open Source Virtual Bronchoscope Navigation System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001984', 'term': 'Bronchial Neoplasms'}], 'ancestors': [{'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': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'necessary upgrades of essential software were not delivered', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions', 'timeFrame': '48 hours', 'description': 'The proportion of cases in which the use of the system is considered beneficial'}], 'secondaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': '1 week', 'description': 'Diagnostic success defined as cytology or biopsy with pathology'}, {'measure': 'Duration of procedure', 'timeFrame': '48 hours', 'description': 'Time spent with preparations and bronchoscopy'}, {'measure': 'Adverse events', 'timeFrame': '48 hours', 'description': 'Procedure related adverse events or unexpected incidents registrated'}, {'measure': 'Operators-reported satisfaction', 'timeFrame': '48 hours', 'description': 'Enquiry on main operator´s experience after end of bronchoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchoscopy', 'Navigation', 'Feasibility Studies'], 'conditions': ['Bronchial Neoplasms']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility of the Fraxinus Virtual Bronchoscope Navigation (VBN) System in the bronchoscopic access to target lesions. The study emphasizes the system´s efficacy in diagnostics of peripheral pulmonary lesions and the ease of use for the operator.', 'detailedDescription': 'Multi-center study. The study explores Fraxinus which is an open source, software only, simple guiding system for bronchoscopy. The system provides 3D maps with centerline-to-target information extracted from preoperative computed tomography. The ability of the system to guide a user to a peripheral target lesion will be evaluated. During bronchoscopy any established method for diagnostic sampling is allowed. User Evaluation will be essential to decide if the Fraxinus VBN System is beneficial in a clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patents with undiagnosed peripheral pulmonary lesion(s) who have been recommended for bronchoscopy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referred to thoracic department in any of the participating hospitals with undiagnosed peripheral pulmonary lesion(s) not visible by bronchoscopy\n* voluntary signed an informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* Any patient that the Investigator feels is not appropriate for this study for any reason'}, 'identificationModule': {'nctId': 'NCT03745859', 'briefTitle': 'Evaluation of a New Open Source Virtual Bronchoscope Navigation System', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System', 'orgStudyIdInfo': {'id': '2018/302'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fraxinus VBN system', 'type': 'DEVICE', 'otherNames': ['Virtual Bronchoscopic Navigation System'], 'description': 'Open source planning tool for bronchoscopy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Hanne Sorger, md phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'SINTEF Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}