Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-06 @ 2:57 PM
Study NCT ID:
NCT04092192
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forceps vs. Snare IVC Filter Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Removal success rate', 'timeFrame': 'Procedure date', 'description': 'Data will be analyzed by a biostatistician to determine statistical differences between cohorts with respect to outcome measures.'}, {'measure': 'Flouroscopy time', 'timeFrame': 'Procedure start to finish', 'description': 'Venography will be performed using a flush catheter and contrast material to evaluate for tip embedding. After filter retrieval, repeat venography will be performed to evaluate for thrombosis, caval spasm, caval perforation, fractured fragments, and other potential complications.'}, {'measure': 'Costs', 'timeFrame': 'Date of procedure up through 6 months following IVC filter removal', 'description': 'Costs associated with filter removal encounter'}, {'measure': 'Procedure related complications', 'timeFrame': 'Date of procedure through 6 months following IVC filter removal', 'description': 'After hemostasis is achieved, patients will be monitored for 2-4 hours in the interventional radiology recovery area.\n\nOne month after filter retrieval, patients will be seen in clinic for follow-up. During this visit, a physicial assessment will done, including adverse events and review of medications.\n\nSix months after filter retrieval, patient will be contacted by telephone for follow-up. Adverse event and medication review will be performed during this call.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['IVC filter, filter removal, filter retrieval'], 'conditions': ['DVT']}, 'descriptionModule': {'briefSummary': "IVC filters are mechanical filters placed in a patient's body to trap blood clots in the legs migrating to the lungs. When no longer indicated, interventional radiologists are consulted for IVC filter removal. Currently, many methods for extracting IVC filters exist. Two of the most common methods involve using an endovascular snare device or rigid forceps. We intend to prospectively compare these two methods in an attempt to see if one offers an advantage to the other. This will be compared by evaluating success rates and procedure time.", 'detailedDescription': 'Currently the optimal method for IVC filter retrieval with respect to success rate and fluoroscopic time (i.e. radiation exposure) is poorly understood. Both snare and forcep techniques have independently evaluated in literature but have never been compared directly. The proposed study would prospectively assess whether one of these established technique offers an advantage with respect to either of these variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant females\n* Adult patients (age 18 years and older)\n* Referred to Interventional Radiology for IVC filter removal\n* IVC filter implanted less than 6 months with the procedure being performed at UCMC by current IR staff.\n* Cook Celect filter or Argon Medical Option Elite\n\nExclusion Criteria:\n\n* Patients with outside hospital filter placement\n* Filters other than Cook Celect or Argon Medical Option Elite\n* Implantation period \\>6 months\n* Evidence of coagulopathy (INR \\<1.8, platelet count \\>50k)\n* Clotting disorder\n* Central venous occlusion\n* Prior filter placement/removal.'}, 'identificationModule': {'nctId': 'NCT04092192', 'briefTitle': 'Forceps vs. Snare IVC Filter Removal', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Prospective Comparison of Rigid Forceps Versus Endovascular Snare for Routine IVC Filter Retrieval', 'orgStudyIdInfo': {'id': 'IRB 18-1502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Forceps', 'description': 'Subjects randomized to this cohort will have their IVC filter removed using a rigid forceps device that will be used to engage the filter apex directly and allow for the filter to be capture/removed.', 'interventionNames': ['Device: IVC filter removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Snare', 'description': 'Subjects randomized to this cohort will have their IVC filter removed using an endovascular snare (like a lasso) device that is designed to catch the hook of the filter and allow it to be captured.', 'interventionNames': ['Device: IVC filter removal']}], 'interventions': [{'name': 'IVC filter removal', 'type': 'DEVICE', 'description': 'In the clinic, it will be explained to patient that they are asked to participate in a study that would randomize them to one of two established techniques for IVC filter removal. It will be explained these are both techniques that are used by interventional radiologists normally used for IVC filter retrieval.\n\nOne technique would be the utilization of an endovascular snare (like a lasso) device that is designed to catch the hook of the filter and allow it to be captured.\n\nThe other technique described will be the usage of a rigid forceps device that will be used to engage the filter apex directly and allow for the filter to be capture/removed.', 'armGroupLabels': ['Forceps', 'Snare']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Osmanuddin Ahmed, M.D.', 'role': 'CONTACT', 'email': 'oahmed@uchicago.edu', 'phone': '773-795-7226'}, {'name': 'Pamela Lofton, RN, MSN', 'role': 'CONTACT', 'email': 'plofton@uchicago.edu', 'phone': '773-702-2537'}], 'facility': 'UChicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Osmanuddin Ahmed, MD', 'role': 'CONTACT', 'email': 'oahmed@uchicago.edu', 'phone': '773-795-7226'}, {'name': 'Pamela Lofton, RN, MSN', 'role': 'CONTACT', 'phone': '773-702-2537'}], 'overallOfficials': [{'name': 'Osmanuddin Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UChicago Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}