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Congenital Diaphragmatic HerniaPregnancyRare diseaseDevice

What this study is

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

What's being tested

  • Fetal Tracheal Occlusion

    Intervention · DEVICE

    Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of <25%, LHR <1, o/e LHR<30% (moderate), singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days, no maternal disease, maternal age > 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.

Study details

Sponsor
Children's Hospital Medical Center, Cincinnati
Conditions
Congenital Diaphragmatic Hernia · Pulmonary Hypoplasia · Pulmonary; Hypertension
Enrolling
40 people
Starts
2016-11
Est. completion
2026-12
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗