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PREEMIE: Study for Treatment of PDA in Premature Infants

Study acronym: PREEMIE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 2026 → Nov 2026
See other at-risk trials from Merit Medical Systems, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Nov 2026
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 7 of 9 sites
  2. Study sites: 10 to 9v9
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v8
  4. Primary completion date: Jun 2026 to Aug 2026
    • Study completion date: Jun 2026 to Mar 2029
    • Site details revised at 3 of 10 sites
    v7
  5. Study sites: 9 to 10
    • Eligibility criteria shortened, about 18 words
    v6
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  1. Site details revised at 9 of 9 sitesv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 9
    • Start date changed from estimate of Feb 2025 to Mar 6, 2025
    v4
  3. Start date: Sep 2024 to Feb 2025v3
  4. Study title shortened, about 4 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.
Trial Details
NCT Number NCT06587282
Lead Sponsor Merit Medical Systems, Inc.
Conditions
(from sponsor)		 Patent Ductus Arteriosus (PDA)
Related terms Ductus Arteriosus, Patent
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov