Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 10:23 AM
Study NCT ID:
NCT00588757
Status:
UNKNOWN
Last Update Posted:
2008-01-09
First Post:
2007-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-01-08', 'studyFirstSubmitDate': '2007-12-25', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing the two filters', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVC filters', 'Trauma', 'Dwell time'], 'conditions': ['Trauma', 'Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'OptEase filters are easier to retrieve but the dwell time is shorter than the Gunter filters. There are more thrombi on the OptEase than on the Gunter at the time of retrieval. OptEase filter has a better infitration capabillity due to its diamond shape. OptEase filters will hjave more IVC occlusions as a complication.', 'detailedDescription': 'We will isert the two filters blindly. We will follow the patients clinically and if needed we will add imaging exams. We will try to retrieve most filters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients referred for filter insertion\n\nExclusion Criteria:\n\n* Young age (\\<18 years)'}, 'identificationModule': {'nctId': 'NCT00588757', 'briefTitle': 'Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Prospective Comparison Between OptEase and Gunter-Tulip', 'orgStudyIdInfo': {'id': 'SHEBA-07-4741-UR-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Optease filter', 'interventionNames': ['Device: Optease IVC filters']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Tulip filter', 'interventionNames': ['Device: Gunter-Tulip IVC filters']}], 'interventions': [{'name': 'Optease IVC filters', 'type': 'DEVICE', 'description': 'IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.', 'armGroupLabels': ['1']}, {'name': 'Gunter-Tulip IVC filters', 'type': 'DEVICE', 'description': 'IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'contacts': [{'name': 'Uri Rimon, MD', 'role': 'CONTACT', 'email': 'rimonu@sheba.health.gov.il', 'phone': '97235302673'}, {'name': 'Uri Rimon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Uri Rimon, MD', 'role': 'CONTACT', 'email': 'rimonu@sheba.health.gov.il', 'phone': '97235302673'}], 'overallOfficials': [{'name': 'Uri Rimon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Uri Rimon', 'oldOrganization': 'Sehba Medical Center'}}}}