Study on the safety and performance of Celect Platinum Vena Cava Filters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect patient-level data on the Celect Platinum Vena Cava Filter and the Gunther Tulip Retrieval Set to assess their safety and performance over time. It will monitor patients who have undergone procedures involving these filters, gathering data for up to five years to evaluate the long-term outcomes while the filters remain indwelling. The study will help confirm the continued acceptability of the benefit-to-risk ratio associated with these devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Hospital Universitari de Bellvitage
  Barcelona, Spain Recruiting
• Hospital Reina Sofia de Cordoba
  Córdoba, Spain Recruiting
• Parc Tauli
  Sabadell, Spain Recruiting
• Leeds Teaching Hospital NHS Trust
  Leeds, West Yorkshire, United Kingdom Recruiting
• Hull University Teaching Hospitals NHS Trust
  Hull, United Kingdom Recruiting

Study contacts

• Study coordinator: Sabina Andersen
• Email: sabina.hjorth@cookmedical.com
• Phone: +45 29 73 41 34

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.