Balloon in the womb: could it save babies with underdeveloped lungs?
NCT ID NCT04583644
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests a procedure called FETO in 10 unborn babies with severe left congenital diaphragmatic hernia (CDH). In CDH, a hole in the diaphragm allows organs to move into the chest, preventing normal lung growth. FETO involves placing a tiny balloon in the baby's windpipe via fetoscopy to block fluid outflow, stretching the lungs and encouraging growth. The balloon is removed later in pregnancy. The goal is to see if the procedure is feasible and safe enough to study further.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery with a balloon device
- What this could lead to
- If successful, this procedure could help severely affected babies with CDH grow more lung tissue before birth, potentially improving their chances of survival after delivery.
- What could go wrong
- This is a very small pilot study (10 participants) focused on feasibility, not yet on proven outcomes. The procedure carries risks for both mother and fetus, including preterm labor or balloon complications.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of California San Francisco Fetal Treatment Center
RECRUITINGSan Francisco, California, 94158, United States
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