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NCT05881798 · ClinicalTrials.gov registry record
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
A clinical trial, sponsored by Cook Research Incorporated.
- Recruiting
- Registry status
- 82
- Enrollment target
NCT05881798: Recruiting study, sponsored by Cook Research Incorporated.
NCT05881798 is a clinical trial that is actively recruiting participants, run by Cook Research Incorporated. The registered enrollment target is 82 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05881798 is actively recruiting participants, sponsored by Cook Research Incorporated.
- RECRUITING
- Registry status
- 82 participants
- Enrollment target
Study Summary
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
Primary Outcome
Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (\>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death.
Interventions
- DEVICE Celect Platinum Vena Cava Filter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2025-06-02 |
| Est. Completion | 2030-12 |
What NCT05881798 shows while recruiting
NCT05881798 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 82 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Celect Platinum Vena Cava Filter is the first listed.
NCT05881798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05881798 about?
NCT05881798 is a clinical study titled "Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study". This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and conti...
What is the current status of trial NCT05881798?
This trial is currently recruiting. The enrollment target is 82 participants. The study started on 2025-06-02. Estimated completion is 2030-12.
What interventions are being tested in trial NCT05881798?
The interventions under investigation include: Celect Platinum Vena Cava Filter (DEVICE).
Who is sponsoring clinical trial NCT05881798?
This trial is sponsored by Cook Research Incorporated, which has 24 total clinical trials registered on ClinicalTrials.gov.
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