Pulmonary EmbolismPhase 4NCT00196118
Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
A Phase 4 study testing Günther Tulip Vena Cava Filter in people with Pulmonary Embolism and Venous Thromboembolism, run by Cook Group Incorporated at 17 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism
- What is being tested?
- Günther Tulip Vena Cava Filter
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2005to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.
- Patient must have a patent internal jugular vein.
- Patient has given informed consent.
Who cannot join
- Patient is less than 18 years.
- Patient has a pre-existing filter
- Patient had indications for a permanent filter at the time of the initial evaluation.
- Patient has uncontrollable coagulopathy.
- Patient has a short life expectancy < 6 months.
- Patient has metastatic malignancy.
Show all 13Show fewer
- Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
- Patient has a contrast allergy that cannot be adequately pre-medicated.
- Patient is at risk of septic embolism.
- Patient has sepsis.
- Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.
- Patient has impaired renal function (creatinine > 2.0).
- Patient is pregnant or planning to become pregnant within the next 6 months
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
INOVA Alexandria
Alexandria, Virginia, 22304
Atlanta Medical Center
Atlanta, Georgia, 30312
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Chicago Hospital
Chicago, Illinois, 60637
Spectrum Health Butterworth & Blodgett Campuses
Grand Rapids, Michigan, 49503
Indiana University Medical Center
Indianapolis, Indiana, 46202
Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute
Miami, Florida, 33176
Christiana Hospital
Newark, Delaware, 19718
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Oregon Health & Sciences University
Portland, Oregon, 97201
Rhode Island Hospital
Providence, Rhode Island, 02903
Utah Valley Regional Medical Center Department of Radiology
Provo, Utah, 84605
LDS Hospital: Department of Radiology
Salt Lake City, Utah, 84103
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Non-Randomized Prospective Study of IVC Filter Retrieval
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.
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Being tested
- Günther Tulip Vena Cava Filter
- Keywords
- Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Günther Tulip Vena Cava FilterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful filter retrieval following implant.
Secondary outcomes (1)
The rate of complications related to Inferior Vena Cava Filter use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bob Smouse, MD, Principal investigator, Peoria Radiology Research & Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196118
- Sponsor's protocol ID
- 04-507-01
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 11 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Prospective Study of IVC Filter Retrieval
- ClinicalTrials.gov ID
- NCT00196118
- Acronym / sponsor ID
- 04-507-01
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Keywords
- Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jul 2007
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.
- Patient must have a patent internal jugular vein.
- Patient has given informed consent.
Key exclusion criteria (13 listed)
- Patient is less than 18 years.
- Patient has a pre-existing filter
- Patient had indications for a permanent filter at the time of the initial evaluation.
- Patient has uncontrollable coagulopathy.
- Patient has a short life expectancy < 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Günther Tulip Vena Cava Filter | Device | – |
Primary outcome
The rate of successful filter retrieval following implant.
1 secondary outcome
The rate of complications related to Inferior Vena Cava Filter use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bob Smouse, MD principal investigator
Peoria Radiology Research & Education Foundation
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Günther Tulip Vena Cava Filter in people with Pulmonary Embolism and Venous Thromboembolism, run by Cook Group Incorporated at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful filter retrieval following implant.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2007.