Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-04-17 @ 12:43 PM
Study NCT ID:
NCT01397292
Status:
TERMINATED
Last Update Posted:
2013-03-19
First Post:
2011-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry for Patients Undergoing Pulmonary Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'whyStopped': 'funding/ enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-15', 'studyFirstSubmitDate': '2011-07-15', 'studyFirstSubmitQcDate': '2011-07-15', 'lastUpdatePostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bronchoscopy', 'Interventional Pulmonary', 'Pleuroscopy', 'Tracheostomy'], 'conditions': ['Pulmonary Procedures']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to examine the safety, tolerability, and effectiveness of currently available pulmonary procedures when used to diagnose or treat different diseases.\n\nThis study will collect information that may influence the outcome of the procedure and identify factors that may affect the procedures yield or safety. The information will be entered into a registry or data storage.', 'detailedDescription': 'This is a retrospective and prospective data registry of all pulmonary diagnostic and therapeutic interventional pulmonary procedures at a single academic center. All pulmonary procedures upon completion will be entered into a database by the participating investigator performing the procedure. For both diagnostic and therapeutic cases, the data will require additional input 1-4 weeks after the procedure in order to place the diagnosis and follow-up data. Retrospective data will only be collected for patients that had their procedures prior to approval of this registry.\n\nStudy data will be collected and managed using REDCap (Research Electronic Data Capture) electronic data (CTSA Awared - Award Number UL1RR031990) capture tools hosted at Virginia Commonwealth University. REDCap is a secure, web-based application designed to support data capture for research studies.\n\nThe prison population will also be included in the registry in order to examine the effects of pulmonary procedures on a special population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ONLY ADULT PATIENTS (\\>18 YEARS OLD) that have a planned PULMONARY PROCEDURE will be potential participants. This will also include a special group, prisoners.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ADULT PATIENTS (\\>18 YEARS OLD) that have a planned PULMONARY PROCEDURE\n\nExclusion Criteria:\n\n* ALL KNOWN PREGNANT PATIENTS WILL BE EXCLUDED FROM THIS REGISTRY.'}, 'identificationModule': {'nctId': 'NCT01397292', 'briefTitle': 'Registry for Patients Undergoing Pulmonary Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Registry Examining Retrospective and Prospective Data for Patients Undergoing Pulmonary Procedures', 'orgStudyIdInfo': {'id': 'HM13603'}}, 'contactsLocationsModule': {'locations': [{'zip': '23060', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Hans J Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}