Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

Recruiting N/A Interventional Study
Congenital Diaphragmatic Hernia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 50
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
15 (estimated)
Sponsor
Yair Blumenfeld · Other
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About This Trial
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benef…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Maternal Age: 18-50 * Singleton gestation * Gestational age before 29 weeks 6 days * Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung vo…
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