Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Cook Research Incorporated
- Study ID
- NCT05881798
- Status
- Recruiting
Conditions
- Deep Vein Thrombosis
- Pulmonary Embolism
- Venous Thromboembolism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Celect Platinum Vena Cava Filter — DEVICEInferior vena cava filter
Study Details
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.
Key Dates
- Start date
- Jun 2, 2025
- Status verified
- Apr 2026
- Primary completion
- Oct 31, 2026
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 82 participants (estimated)
Arms
- Arm: Patients indicated for the placement of a Celect Platinum Vena Cava FilterPatients indicated for the placement of a Celect Platinum Vena Cava Filter
Primary Outcome Measure
Filter-related primary endpoint (safety) [ Time Frame: Index procedure through 12-months post procedure ]
Central Contacts
- Sabina Andersen+45 29 73 41 34
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | - |
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