Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-31 @ 2:07 AM
Study NCT ID:
NCT01597869
Status:
UNKNOWN
Last Update Posted:
2013-01-03
First Post:
2012-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-01', 'studyFirstSubmitDate': '2012-05-10', 'studyFirstSubmitQcDate': '2012-05-10', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications related with EBUS-TBNA', 'timeFrame': '1 month interval', 'description': '1. Complications during procedure\n\n * Bleeding\n * pneumothorax\n * shock\n * cardiac arrythmia\n * change of oxygen saturation\n2. Complication after procedure\n\n * fever\n * bleeding\n * pneumothorax\n * all other comlications after 24hr'}], 'secondaryOutcomes': [{'measure': 'Risk factors related with the development of complications', 'timeFrame': '1 month interval', 'description': '1. Midazolam/Lidocaine dosage\n2. Procedure time\n3. Total aspiration number\n4. Location of sampled lymph node\n5. Sampling number of lymph nodes\n6. Underlying disease\n7. Pulmonary function test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ultrasound', 'Complication']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find all kinds of complications and it's frequency related to the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to evaluate associated risk factors in patients who developed complications. The investigators performs EBUS-TBNA examination on all subjects that need mediastinal evaluation. All complications during or after the procedure will be recorded prospectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admmitted to the tertiary hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mediastinal lymph node enlargement on chest CT or PET-CT\n\nExclusion Criteria:\n\n* Inadequate oxygenation during procedure\n* uncontrolled cardiac arrythmia\n* Bleeding diathesis\n* Severe thrombocytopenia\n* Recent use of clopidogrel\n* Uncooperative patients'}, 'identificationModule': {'nctId': 'NCT01597869', 'briefTitle': 'Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study', 'orgStudyIdInfo': {'id': '2012-02-009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endobronchial ultrasound', 'type': 'DEVICE', 'description': 'EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung Jong Lee, MD', 'role': 'CONTACT', 'email': 'kj2011.lee@samsung.com', 'phone': '+82-2-3410-0777'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kyung Jong Lee, MD', 'role': 'CONTACT', 'email': 'kj2011.lee@samsung.com', 'phone': '+82-2-3410-0777'}], 'overallOfficials': [{'name': 'Kyung Jong Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Kyung Jong Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}