RECRUITINGOBSERVATIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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 willing to sign a consent form.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Celect Platinum Vena Cava Filter
Inferior vena cava filter
Locations (6)
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