NYU Langone Health
The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34 weeks and 6 days of gestation. The primary endpoint is successful placement and removal of the balloon.
Inclusion Criteria: 1. Provision of a signed and dated informed consent form 2. Pregnant individuals age 18 years and older 3. Singleton pregnancy 4. A normal karyotype with confirmation by culture results, CMA with non-pathologic variants, whole exome or genome sequencing (WES or WGS). 5. Isolated left CDH with severe pulmonary hypoplasia with o/e LHR less than 25% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation) 6. Isolated right CDH with severe pulmonary hypoplasia with o/e LHR equal or less than 30% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days o…
GOLDBAL2 will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100).
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