Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
Vincent Duron
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).
Description
Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year. The defect in the fetal diaphragm allows abdominal organs (intestine, stomach, liver, spleen) to migrate into the thorax, hindering normal lung development. The herniated contents place pressure on the developing lungs and this may result in varying degrees of pulmonary hypoplasia and associated pulmonary hypertension; both of which may be lethal. In an attempt to prenatally quantify the impact of the herniated organs on underlying lung development, prognostic tools have been developed. The most widely used…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study 3. Pregnant women, age 18 years and older 4. Singleton pregnancy 5. No pathogenic variants on microarray or pathologic findings on karyotype; results by fluorescence in situ hybridization (FISH) will be acceptable if patient is \>26 weeks 6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects 7. Fetal CDH (left or right) with severe pulmonar…
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)
Location
- Columbia University Irving Medical Center/NewYork-PresbyterianNew York, New York