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Balloon in the womb: new hope for babies with severe birth defect?

NCT ID NCT03138863

Recruiting now Disease control Sponsor: Rodrigo Ruano Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a procedure called FETO for unborn babies with a severe form of congenital diaphragmatic hernia (CDH), where the diaphragm has a hole and the lungs don't grow well. Doctors place a tiny balloon in the baby's windpipe to block it, which may help the lungs expand and grow. The trial will enroll 10 pregnant women to see if the procedure is safe and can be done successfully.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

BALT GoldbBAL2 Detachable Balloon and catheter system

What this could lead to

If successful, this procedure could improve lung growth and survival in babies with severe congenital diaphragmatic hernia.

What could go wrong

This is a very small early study (10 participants) focused on safety and feasibility. The procedure carries risks like preterm labor, infection, or premature balloon removal. It may not improve outcomes.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia Familial Primary Pulmonary Hypertension pulmonary arterial hypertension pulmonary hypoplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONGENITAL DIAPHRAGMATIC HERNIA PULMONARY ARTERY HYPERTENSION PULMONARY HYPOPLASIA

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Mayo Clinic

    TERMINATED

    Rochester, Minnesota, 55905, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••