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RECRUITING
NCT06587282
NA

PREEMIE: Study for Treatment of PDA in Premature Infants

Sponsor: Merit Medical Systems, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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