Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:20 AM
Study NCT ID:
NCT07418450
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discrimination of N2a and N2b by EBUS-TBNA: is a Change of the Needle Necessary?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between the two rounds of EBUS staging', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'During EBUS staging in patients with mediastinal lymphadenopathy, it is planned to perform a first round of staging with change of the needle between all lymph nodes and a second round of staging without change of the needle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pulmonary lesion suspicious for lung cancer or histologically confirmed lung cancer\n* indication for mediastinal staging\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07418450', 'briefTitle': 'Discrimination of N2a and N2b by EBUS-TBNA: is a Change of the Needle Necessary?', 'organization': {'class': 'OTHER', 'fullName': 'University of Vienna'}, 'officialTitle': 'Discrimination of N2a and N2b by EBUS-TBNA: is a Needle Change Necessary? - a Prospective Pilot Study', 'orgStudyIdInfo': {'id': '1.1 Needle change'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STudy group', 'interventionNames': ['Diagnostic Test: EBUS-TBNA']}], 'interventions': [{'name': 'EBUS-TBNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'During EBUS staging, the needle well be changed between all lymph node stations in a first round. The EBUS staging will be repeated without the change of the needle between the lymph node stations.', 'armGroupLabels': ['STudy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Daniela Gompelmann', 'role': 'CONTACT', 'email': 'daniela.gompelmann@meduniwien.ac.at', 'phone': '0043 1 40400 47730'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Daniela Gompelmann', 'role': 'CONTACT', 'email': 'daniela.gompelmann@meduniwien.ac.at', 'phone': '0043 1 40400 47730'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Daniela Gompelmann', 'investigatorAffiliation': 'University of Vienna'}}}}