RecruitingNot ApplicableNCT05354505

Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)


Sponsor

Vincent Duron

Enrollment

10 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot trial tests a prenatal procedure called FETO (Fetal Endoscopic Tracheal Occlusion) for severe cases of congenital diaphragmatic hernia (CDH), a birth defect where abdominal organs move into the chest and prevent the baby's lungs from developing properly. The procedure temporarily blocks the baby's airway in the womb to stimulate lung growth, potentially improving survival after birth. Eligible participants are pregnant women aged 18 or older carrying a single fetus with severe CDH (very underdeveloped lungs) who can live near Columbia University Irving Medical Center in New York for the remainder of the pregnancy. Participation requires the FETO procedure at 27–30 weeks of pregnancy, close monitoring, delivery at the study center, and compliance with activity restrictions during the pregnancy. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPlacement of the GOLDBAL2 balloon

The Fetal Endoscopic Tracheal Occlusion (FETO) procedure using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) will be used to treat fetuses diagnosed with severe Congenital Diaphragmatic Hernia (CDH)


Locations(1)

Columbia University Irving Medical Center/NewYork-Presbyterian

New York, New York, United States

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NCT05354505