Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02109458
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lyarmus@jhmi.edu', 'phone': '4105025224', 'title': 'Dr. Lonny Yarmus', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Assessing Peripheral Pulmonary Nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).\n\nNavigation guided bronchoscopy', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hemoptysis', 'notes': 'Blood in sputum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessing Peripheral Pulmonary Nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).\n\nNavigation guided bronchoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following procedure', 'description': 'Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Pneumothorax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessing Peripheral Pulmonary Nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).\n\nNavigation guided bronchoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after procedure', 'description': 'Presence of pneumothorax assessed in participants with successful completion of biopsy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessing Peripheral Pulmonary Nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).\n\nNavigation guided bronchoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 1 week upon receipt of pathology report', 'description': 'Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Assessing Peripheral Pulmonary Nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).\n\nNavigation guided bronchoscopy'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 1 week upon receipt of pathology report', 'description': 'Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Assessing Peripheral Pulmonary Nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).\n\nNavigation guided bronchoscopy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Assessing Peripheral Pulmonary Nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).\n\nNavigation guided bronchoscopy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2014-03-17', 'resultsFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-13', 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': 'Immediately following procedure', 'description': 'Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)'}, {'measure': 'Incidence of Pneumothorax', 'timeFrame': 'Immediately after procedure', 'description': 'Presence of pneumothorax assessed in participants with successful completion of biopsy.'}], 'secondaryOutcomes': [{'measure': 'Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone', 'timeFrame': 'Approximately 1 week upon receipt of pathology report', 'description': 'Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.'}, {'measure': 'Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB', 'timeFrame': 'Approximately 1 week upon receipt of pathology report', 'description': 'Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung nodule biopsy'], 'conditions': ['Peripheral Pulmonary Nodules']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (PPN).', 'detailedDescription': 'Accessing peripheral pulmonary nodules is problematic because they are often not visible endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial biopsy (TBBx), and/or do not lie within an accessible airway. In this study, investigators hope to evaluate new technologies to aid in PPN biopsy using navigation bronchoscopy (NB) combined with navigation transthoracic needle aspiration (N-TTNA) sampling of a PPN.\n\nPatients meeting inclusion criteria who consent will undergo a convex Endobronchial Ultrasound (EBUS) bronchoscopy for evaluation and sampling of the mediastinum and hilum. Following this, NB will be performed with an ultrathin bronchoscope (4mm outer diameter with a 2 mm working channel) with R-EBUS and fluoroscopy. If the lesion is localized by NB and/or radial EBUS in conjunction with NB, TBBX will be taken. At the conclusion of TBBX sampling, a fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if one is present, appropriate clinical measures will be taken at the discretion of the treating team (tube thoracostomy, observation, etc.) and no further sampling techniques will be utilized. If the lesion was not able to be localized via NB and/or the physician feels insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the patient will undergo N-TTNA at the same PPN during the same procedure time. It is envisioned that between 8-12 patients will require a N-TTNA to complete diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Target patient population: Patients with a peripheral pulmonary nodule as identified on CT chest ≤3cm from the pleura will be recruited. A PPN will be defined as a lesion \\>10mm and \\<3cm in diameter surrounded by lung parenchyma on CT chest. The decision for biopsy of the PPN will be made by the treating physician and agreed upon by the patient.\n* Participants must be at least 18 years old or older\n* No bleeding disorders\n* Provide informed consent.\n\nExclusion criteria\n\n* less than 18 years\n* lack of fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure\n* inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT02109458', 'briefTitle': 'Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Navigational Bronchoscopy and Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Nodules: A Safety and Feasibility Pilot', 'orgStudyIdInfo': {'id': 'NA_00086035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assessing peripheral pulmonary nodules', 'description': 'To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).', 'interventionNames': ['Device: Navigation guided bronchoscopy']}], 'interventions': [{'name': 'Navigation guided bronchoscopy', 'type': 'DEVICE', 'description': 'Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.', 'armGroupLabels': ['Assessing peripheral pulmonary nodules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Lonny Yarmus, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Veran Medical Technologies', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}