Non-invasive Removal of the Smart Tracheal Occlusion Device for Fetal Congenital Diaphragmatic Hernia: A Feasibility Study
The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia.
• Women carrying a fetus with isolated CDH eligible for FETO, i.e. with severe or moderate hypoplasia:
‣ Left sided CDH with severe (i.e. quotient of observed-to-expected- lung-to-head ratio under 25%) or moderate pulmonary hypoplasia (observed-to-expected- lung-to-head ratios of 25 to 34.9% (any liver position), or 35 to 44.9% with intrathoracic liver herniation)
⁃ Right sided CDH with severe pulmonary hypoplasia (quotient of observed-to-expected- lung-to-head ratio under 50%)
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Maternal age of 18 years or older
• Single pregnancy
• Signed informed consent
• Consent to have an ultrasound of the uterus after delivery when indicated
• Postnatal management center agrees to participate