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PREEMIE: Study for Treatment of PDA in Premature Infants
Sponsor: Merit Medical Systems, Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
5 Days - Any
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2025-03-06
Completion Date
2029-03
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Bloom Micro Occluder System
Percutaneous transcatheter closure of PDA using Bloom Micro Occluder System
Locations (10)
UC Davis Health
Sacramento, California, United States
UC San Diego-Rady Children's Hospital
San Diego, California, United States
Memorial Healthcare System-Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Washington University-St. Louis Children's Hospital
St Louis, Missouri, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Herma Heart Institute-Children's Wisconsin
Milwaukee, Wisconsin, United States