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NCT02201277 · ClinicalTrials.gov registry record · NA
ODEN Trial: Option vs. Denali IVC Filters
A NA study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT02201277 is a NA study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 45 participants.
The verdict
NCT02201277, a NA study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
This research study is a prospective randomized trial evaluating the relative safety of two inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All eligible patients will have been ordered to have a IVC filter placed by their primary medical team and filters will be placed in these patients whether or not they wish to participate in this trial as part of standard of care. The investigators will follow up with patients 30 days after IVC filter placement and ask them to come back for filter removal if medically appropriate. If removal is not medically appropriate in 30 days, the investigators will attempt to schedule removal every 30 days after initial placement. Primary outcome measures will be IVC filter complications such as filter penetration through the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots formed within the filter. All of these are reported complications of all IVC filters. The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon as it is safe to do so. Hypothesis: The investigators hypothesize that there is no significant difference in efficacy and complication rate between the Option and the Denali filter.
Interventions
- DEVICE Filter Placed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-05-27 |
| Est. Completion | 2018-04-27 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02201277
The ClinicalTrials.gov registry entry for NCT02201277 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Filter Placed is the first listed.
NCT02201277 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02201277 about?
NCT02201277 is a clinical study titled "ODEN Trial: Option vs. Denali IVC Filters". This research study is a prospective randomized trial evaluating the relative safety of two inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All eligible patients will have...
What is the current status of trial NCT02201277?
This trial is currently terminated. It is a NA study. The enrollment target is 45 participants. The study started on 2014-05-27. Estimated completion is 2018-04-27.
What interventions are being tested in trial NCT02201277?
The interventions under investigation include: Filter Placed (DEVICE).
Who is sponsoring clinical trial NCT02201277?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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