Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT00196118
Status:
COMPLETED
Last Update Posted:
2007-12-11
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-07'}, 'lastUpdateSubmitDate': '2007-12-07', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of successful filter retrieval following implant.'}], 'secondaryOutcomes': [{'measure': 'The rate of complications related to Inferior Vena Cava Filter use.'}]}, 'conditionsModule': {'keywords': ['Pulmonary Embolism', 'Venous Thromboembolism', 'Inferior Vena Cava Filter', 'IVC', 'PE'], 'conditions': ['Pulmonary Embolism', 'Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.\n* Patient must have a patent internal jugular vein.\n* Patient has given informed consent.\n\nExclusion Criteria:\n\n* Patient is less than 18 years.\n* Patient has a pre-existing filter\n* Patient had indications for a permanent filter at the time of the initial evaluation.\n* Patient has uncontrollable coagulopathy.\n* Patient has a short life expectancy \\< 6 months.\n* Patient has metastatic malignancy.\n* Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.\n* Patient has a contrast allergy that cannot be adequately pre-medicated.\n* Patient is at risk of septic embolism.\n* Patient has sepsis.\n* Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.\n* Patient has impaired renal function (creatinine \\> 2.0).\n* Patient is pregnant or planning to become pregnant within the next 6 months'}, 'identificationModule': {'nctId': 'NCT00196118', 'briefTitle': 'Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'A Non-Randomized Prospective Study of IVC Filter Retrieval', 'orgStudyIdInfo': {'id': '04-507-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Günther Tulip Vena Cava Filter', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30312', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Medical Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF St. Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Butterworth & Blodgett Campuses', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '84605', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Valley Regional Medical Center Department of Radiology', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital: Department of Radiology', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22304', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'INOVA Alexandria', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}], 'overallOfficials': [{'name': 'Bob Smouse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peoria Radiology Research & Education Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}}}}