Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Parc Tauli
RECRUITING
Sabadell
United Kingdom
Royal Liverpool Hospital
RECRUITING
Liverpool
Contact Information
Primary
Cathrin Rogge
cathrin.rogge@cookmedical.com
+49 151 587 588 58
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2030-04
Participants
Target number of participants: 82
Treatments
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
Related Therapeutic Areas
Sponsors
Leads: Cook Research Incorporated