RecruitingNot ApplicableNCT05450653

Trial of FETO for Severe Congenital Diaphragmatic Hernia

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

Sponsor

Aimen F. Shaaban, MD

Enrollment

10 participants

Start Date

Sep 18, 2022

Study Type

INTERVENTIONAL

Conditions

Congenital Diaphragmatic Hernia

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) for people with congenital diaphragmatic hernia. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)

A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus with severe congenital diaphragmatic hernia (o/e LHR \<25% with liver up) during the FETO procedure between gestational age 27 weeks 0 days and 29 weeks and 6 days. The fetal tracheal balloon will be removed at between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.