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CeraFlex PFO Closure System PMCF Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 5 of 15 sitesv6
  2. Study sites: 10 to 15v5
  3. Primary completion date: Dec 2025 to Dec 2026
    • Study sites: 8 to 10
    • Study completion date: Jul 2027 to Dec 2028
    v4
  4. Study sites: 9 to 8
    • Primary completion date: Jul 2025 to Dec 2025
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2023 to Nov 3, 2023
    • Site details revised at 9 of 9 sites
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.
Trial Details
NCT Number NCT06120270
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions
(from sponsor)		 Patent Foramen Ovale
Related terms Foramen Ovale, Patent
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov