Study on the safety and performance of Celect Platinum Vena Cava Filters
Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study
This study is testing how safe and effective the Celect Platinum Vena Cava Filters are for patients over time after they've had them placed in their bodies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cook Group Incorporated Industry-sponsored |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT05881798 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients who are undergoing a procedure that involves the placement of a Celect Platinum Vena Cava Filter.
Not a fit: Patients who have previously participated in the Cook MDR-2126 study or those unwilling to consent to data collection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Vena Cava filters, potentially improving patient outcomes.
How similar studies have performed: While this study is observational and focuses on post-market data collection, similar studies have previously shown success in confirming the safety and efficacy of medical devices.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 6 other locations
- 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)
- Royal Liverpool Hospital — Liverpool, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sabina Andersen
- Email: sabina.hjorth@cookmedical.com
- Phone: +45 29 73 41 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.