Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
Rodrigo Ruano
Summary
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Singleton pregnancy * Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks. * Isolated Left CDH with liver up * Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) \< 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to \<30% (measured at 300 to 316 weeks) at time of surgery. * Gestational age at FETO procedure with O/E LHR \<25% at 27 weeks 0…
Interventions
- DeviceBALT GoldbBAL2 Detachable Balloon
Latex balloon, with radio-opaque inclusion
- DeviceCatheter System
100 cm tapered micro-catheter
Locations (2)
- University of MiamiMiami, Florida
- Mayo ClinicRochester, Minnesota