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Trial of FETO for Severe Congenital Diaphragmatic Hernia — FETO  

Congenital Diaphragmatic Hernia Clinical Trial

Official title:
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia (CDH)

Clinical Trial Summary

This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.

Clinical Trial Description

A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100) between 27 weeks 0 days and 29 weeks and 6 days of gestation. The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days of gestation or earlier as indicated. After balloon insertion, participants will be followed weekly and must reside within 30 minutes of Lurie Children's until balloon removal. Additionally, participants will have restrictions from return to work, exercise, or intercourse. The children's health status will be followed until two years of age. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05450653
Study type Interventional
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact Aimen Shaaban, MD
Phone 312-227-4747
Email AShaaban@luriechildrens.org
Status Recruiting
Phase N/A
Start date September 18, 2022
Completion date November 2027
View Details
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