Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2018-12-26
2028-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Forceps
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.
IVC filter removal
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.
One 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.
The 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.
Snare
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.
IVC filter removal
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.
One 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.
The 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.
Interventions
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IVC filter removal
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.
One 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.
The 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.
Eligibility Criteria
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Inclusion Criteria
* Adult patients (age 18 years and older)
* Referred to Interventional Radiology for IVC filter removal
* IVC filter implanted less than 6 months with the procedure being performed at UCMC by current IR staff.
* Cook Celect filter or Argon Medical Option Elite
Exclusion Criteria
* Filters other than Cook Celect or Argon Medical Option Elite
* Implantation period \>6 months
* Evidence of coagulopathy (INR \<1.8, platelet count \>50k)
* Clotting disorder
* Central venous occlusion
* Prior filter placement/removal.
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Osmanuddin Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
UChicago Medicine
Locations
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UChicago Medicine
Chicago, Illinois, United States
Countries
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Central Contacts
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Pamela Lofton, RN, MSN
Role: CONTACT
Facility Contacts
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Other Identifiers
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IRB 18-1502
Identifier Type: -
Identifier Source: org_study_id
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