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Active, not recruiting Not applicable Interventional

PREEMIE: Study for Treatment of PDA in Premature Infants

ClinicalTrials.gov ID: NCT06587282

Public ClinicalTrials.gov record NCT06587282. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06587282
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Merit Medical Systems, Inc.
Industry
Enrollment
55 participants

Conditions and interventions

Eligibility (public fields only)

Age range
5 Days and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 6, 2025 (Actual)
Primary completion
Nov 2026 (Estimated)
Completion
Mar 2029 (Estimated)
Last update posted
Oct 7, 2026

2025 – 2029

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
UC Davis Health Sacramento California 95817 —
UC San Diego-Rady Children's Hospital San Diego California 92123 —
Memorial Healthcare System-Joe DiMaggio Children's Hospital Hollywood Florida 33021 —
Nicklaus Children's Hospital Miami Florida 33155 —
Children's Healthcare of Atlanta Atlanta Georgia 30342 —
Washington University-St. Louis Children's Hospital St Louis Missouri 63110 —
Le Bonheur Children's Hospital Memphis Tennessee 38103 —
UT Southwestern Medical Center Dallas Texas 75390 —
Herma Heart Institute-Children's Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06587282, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 7, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06587282 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →