Balloon in the womb: new device aims to save babies with underdeveloped lungs

NCT ID NCT04931212

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

Summary

This study tested a new device (Smart-TO) that places a small balloon in the windpipe of unborn babies with congenital diaphragmatic hernia, a condition where the diaphragm has a hole and the lungs don't grow properly. The balloon is later removed using a special MRI technique. The goal was to see if the device works and is safe. 23 pregnant women participated, and the study focused on whether the balloon deflated and came out as planned, and on any side effects like early birth.

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia pulmonary hypoplasia

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Béclère

    Clamart, 92140, France