Trials / Active Not Recruiting
Active Not RecruitingNCT06587282
PREEMIE: Study for Treatment of PDA in Premature Infants
Multicenter, Single Arm Prospective, Non-Randomized Study 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 (PREEMIE)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- Merit Medical Systems, Inc. · Industry
- Sex
- All
- Age
- 5 Days
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bloom Micro Occluder System | Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System |
Timeline
- Start date
- 2025-03-06
- Primary completion
- 2026-08-01
- Completion
- 2029-03-01
- First posted
- 2024-09-19
- Last updated
- 2026-04-13
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06587282. Inclusion in this directory is not an endorsement.