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Recruiting NCT05881798

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

Conditions: Deep Vein Thrombosis Venous Thromboembolism Pulmonary Embolism

Sponsor: Cook Research Incorporated

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Celect Platinum Vena Cava Filter
DEVICE
Locations 7
Spain (3)
Hospital Universitari de Bellvitage
Barcelona
Hospital Reina Sofia de Cordoba
Córdoba
Parc Tauli
Sabadell
United Kingdom (3)
Hull University Teaching Hospitals NHS Trust
Hull
Leeds Teaching Hospital NHS Trust
Leeds , West Yorkshire
Royal Liverpool Hospital
Liverpool
United States (1)
Cedars-Sinai Medical Center
Los Angeles , California
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.06.2025
Completion date
01.12.2030
Registry ID
NCT05881798
Source
clinicaltrials.gov
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