Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
Recruiting now
Conditions studied: Deep Vein Thrombosis, Venous Thromboembolism, Pulmonary Embolism
In brief
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.
Key facts
- Study ID
- NCT05881798
- Run by
- Cook Research Incorporated
- People needed
- 82
- Starts
- 2025-06-02
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
- Subject has not previously participated in the Cook MDR-2126 study.
You may not qualify if…
- Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Hospital Universitari de Bellvitage — Barcelona, Spain (enrolling)
- Hospital Reina Sofia de Cordoba — Córdoba, Spain (enrolling)
- Parc Tauli — Sabadell, Spain (enrolling)
- Leeds Teaching Hospital NHS Trust — Leeds, West Yorkshire, United Kingdom (enrolling)
- Hull University Teaching Hospitals NHS Trust — Hull, United Kingdom (enrolling)
- Royal Liverpool Hospital — Liverpool, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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