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 — DEVICE
    Inferior 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 Filter
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-

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