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

Launched by COOK RESEARCH INCORPORATED · May 30, 2023

Keywords

ClinConnect Summary

This clinical trial is examining two specific medical devices: the Celect Platinum Vena Cava Filter and the Günther Tulip Vena Cava Filter Retrieval Set. These filters are used to help prevent serious conditions like deep vein thrombosis (DVT), venous thromboembolism (VTE), and pulmonary embolism (PE), which can occur when blood clots travel to the lungs. The goal of the study is to gather information on how safe and effective these filters are over time, specifically looking at data from patients for up to five years after the filters are placed.

To be eligible for this trial, participants should be individuals who are having the Celect Platinum Vena Cava Filter inserted and have not previously taken part in a related study. It's important to note that anyone who does not agree to have their data collected or who does not want to sign consent will not be able to participate. While the study has not started recruiting participants yet, those who join can expect to provide information about their health and the performance of the filter over the years.

Gender

ALL

Eligibility criteria

• 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.