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Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 6 to 7v14
  2. Study sites: 2 to 6v13
  3. Primary completion date: Feb 2026 to Oct 2026
    • Study completion date: Apr 2030 to Dec 2030
    v12
  4. Start date changed from estimate of May 2025 to Jun 2, 2025
    • Site details revised at 1 of 2 sites
    v11
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 0 to 1
    • Start date: Apr 2025 to May 2025
    v9
  2. Start date: Jan 2025 to Apr 2025v8
  3. Start date: Oct 2024 to Jan 2025v7
  4. Start date: Aug 2024 to Oct 2024
    • Primary completion date: Oct 2025 to Feb 2026
    • Study completion date: Jan 2029 to Apr 2030
    v6
  5. Start date: Jun 2024 to Aug 2024v5
  6. Primary completion date: Jan 2024 to Oct 2025
    • Start date: Jan 2024 to Jun 2024
    • Study completion date: Jan 2024 to Jan 2029
    v4
  7. Start date: Oct 2023 to Jan 2024v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05881798
Lead Sponsor Cook Research Incorporated
Conditions
(from sponsor)		 Deep Vein Thrombosis, Venous Thromboembolism, Pulmonary Embolism
Related terms Pulmonary Embolism, Venous Thromboembolism, Venous Thrombosis
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov