Bloom Micro Occluder System for Patent Ductus Arteriosus

(PREEMIE Trial)

Recruiting at 10 trial locations

Overseen By Vicky Brunk

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Merit Medical Systems, Inc.

Disqualifiers: Coarctation of aorta, Pulmonary stenosis, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Bloom Micro Occluder System, to treat patent ductus arteriosus (PDA), a heart condition in premature infants. The goal is to determine the device's safety and effectiveness over six months. Infants at least five days old, weighing between 600 and 2500 grams, and with a PDA requiring closure might be suitable for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could enhance future PDA treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Bloom Micro Occluder System is safe for treating patent ductus arteriosus in pre-mature infants?

Research is examining the safety and effectiveness of the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature babies. This treatment is specifically designed for small infants with this heart condition. In these studies, researchers closely monitor the Bloom Micro Occluder System to ensure its safety for these babies.

So far, detailed reports of serious problems or side effects have not emerged from these studies. While no guarantees exist regarding risks, the device's testing in premature infants suggests some promise in terms of safety. These studies aim to ensure the treatment is both safe and beneficial for the babies involved. Prospective participants should discuss any concerns with their doctor before joining a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bloom Micro Occluder System is unique because it offers a minimally invasive solution for treating Patent Ductus Arteriosus (PDA). Unlike traditional surgical methods or the use of larger occluders, which can pose greater risks and require longer recovery times, the Bloom system is designed to be smaller and more precise, reducing potential complications and enhancing recovery. Researchers are particularly excited about its potential to improve outcomes for infants and small children, as its design is tailored to accommodate their delicate cardiovascular systems. This innovation could lead to safer and more effective PDA closure procedures, making it a promising alternative to existing treatments.

What evidence suggests that the Bloom Micro Occluder System is effective for treating patent ductus arteriosus?

Research has shown that the Bloom Micro Occluder System might help treat patent ductus arteriosus (PDA) in premature babies. PDA is a heart issue where a blood vessel called the ductus arteriosus doesn't close properly after birth. The Bloom Micro Occluder is designed to safely close this opening. Early results suggest that this system can effectively close the PDA, potentially improving heart function in these babies. More studies, including this trial, are underway to confirm these early findings. ^{1 2 3 4 6}

Who Is on the Research Team?

Howaida El-Said, MD

Principal Investigator

Rady Children's Hospital

Are You a Good Fit for This Trial?

This trial is for premature infants at least 5 days old, diagnosed with a significant PDA (a heart issue where a blood vessel doesn't close after birth) that needs closing. The PDA must be less than or equal to 4mm wide and at least 5mm long. Infants must weigh between 600-2500 grams.

Inclusion Criteria

My pancreatic duct is 5 mm or longer.

My PDA is 4.0 mm or smaller in diameter.

My weight is between 600 and 2500 grams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA)

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bloom Micro Occluder System

Trial Overview The study tests the Bloom Micro Occluder System's safety and effectiveness in treating PDA in preemies over six months. It's a single-group study, meaning all participants receive the same treatment without comparison to another group or placebo.

How Is the Trial Designed?

Group I: PDA treatment Experimental Treatment 1 Intervention

PDA treated with Bloom Micro Occluder System

Who Is Running the Clinical Trial?

Merit Medical Systems, Inc.

Lead Sponsor

Trials

35

Recruited

3,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06587282

PREEMIE: Study for Treatment of PDA in Premature Infants This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the ...

2. medicaldevice-network.com medicaldevice-network.com/news/merit-first-subject-trial/

Merit enrols first subject in trial of Bloom Micro Occluder ... Merit Medical Systems has enrolled the first patient in the multi-centre PREEMIE study to assess the efficacy and safety of the Bloom Micro Occluder System.

3. withpower.com withpower.com/trial/bloom-micro-occluder-system-for-patent-ductus-arteriosus-b7998

Bloom Micro Occluder System for Patent Ductus Arteriosus Trial Overview The study tests the Bloom Micro Occluder System's safety and effectiveness in treating PDA in preemies over six months. It's a single-group study ...

4. citoday.com citoday.com/news/merit-begins-preemie-study-of-bloom-micro-occluder-system

Merit Begins PREEMIE Study of Bloom Micro Occluder ... The PREEMIE study is a multicenter, prospective, investigational device exemption study of the Bloom system, which is not currently approved to treat PDA.

5. trialx.com trialx.com/clinical-trials/listings/296374/preemie-study-for-treatment-of-pda-in-premature-infants/

PREEMIE: Study for Treatment of PDA in Premature Infants This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder ...

6. nasdaq.com nasdaq.com/articles/merit-medical-systems-initiates-preemie-study-bloom-micro-occluder-system-treating-patent

Merit Medical Systems Initiates PREEMIE Study on Bloom ... Merit Medical Systems initiates a study to evaluate the Bloom Micro Occluder System for treating patent ductus arteriosus in premature infants.