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

Plain Language Summary

Simplified for easier understanding

This post-market study is collecting real-world data on the long-term performance of the Celect Platinum Vena Cava Filter — a small metal device placed in the inferior vena cava (the large vein returning blood to the heart) to catch blood clots that might otherwise travel to the lungs and cause a pulmonary embolism. Vena cava filters are used when patients cannot tolerate blood thinners. The Celect Platinum is designed to be retrievable, but real-world retrieval rates, complications, and filter longevity data are important for ongoing safety monitoring. Eligible participants are any adult patients who have had the Celect Platinum filter placed, who have not previously participated in the related Cook MDR-2126 study, and who consent to data collection. Patients who object to their data being used or who are unwilling to sign informed consent are excluded. Clinical and imaging data are collected from patient records at regular follow-up intervals. No additional procedures are performed as part of the study. This registry-style study matters because it supports the ongoing safety surveillance required after a medical device reaches the market, and helps physicians and regulators understand how the filter performs outside the controlled conditions of a clinical trial.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECelect Platinum Vena Cava Filter

Inferior vena cava filter


Locations(7)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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

For the most up-to-date information, visit the official listing.

Visit

NCT05881798


Related Trials