Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCook Research Incorporated
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Celect Platinum Vena Cava Filter
Treatment groups
82 Participants
are divided into 1 treatment groupLocations
7Spain
Hospital Universitari de Bellvitage08907, Barcelona Spain
Hospital Reina Sofia de Cordoba14004, Córdoba Spain
Parc Tauli08208, Sabadell Spain
United Kingdom
Leeds Teaching Hospital NHS TrustLS1 3EX, LeedsWest Yorkshire, United Kingdom
Sponsors and collaborators
Cook Research Incorporated
Lead sponsor
Source ClinicalTrials.gov