RecruitingNCT05881798

Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study

Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study


Sponsor

Cook Research Incorporated

Enrollment

82 participants

Start Date

Jun 2, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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.

Exclusion Criteria1

  • 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.

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Interventions

DEVICECelect Platinum Vena Cava Filter

Inferior vena cava filter


Locations(6)

Hospital Universitari de Bellvitage

Barcelona, Spain

Hospital Reina Sofia de Cordoba

Córdoba, Spain

Parc Tauli

Sabadell, Spain

Leeds Teaching Hospital NHS Trust

Leeds, West Yorkshire, United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Royal Liverpool Hospital

Liverpool, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05881798


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