RecruitingNot ApplicableNCT03138863

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863


Sponsor

Rodrigo Ruano

Enrollment

10 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a procedure called FETO (fetal endoscopic tracheal occlusion) — a surgery done on a baby still in the womb — to help fetuses with a serious condition called congenital diaphragmatic hernia (CDH), where a hole in the diaphragm allows organs to crowd the lungs, preventing them from developing normally. **You may be eligible if...** - You are carrying a single baby (not twins) - Your baby has been diagnosed with an isolated left-sided CDH with the liver pushed up into the chest - Tests show the baby's lung size is severely underdeveloped (based on specific ultrasound measurements) - You are enrolled before 29 weeks and 6 days of pregnancy - Your baby's chromosomes are normal **You may NOT be eligible if...** - You are carrying more than one baby - Your baby has other birth defects in addition to CDH - Your baby has CDH on the right side - The CDH is mild or moderate rather than severe Talk to your doctor to see if this trial is right for you.

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

DEVICEBALT GoldbBAL2 Detachable Balloon

Latex balloon, with radio-opaque inclusion

DEVICECatheter System

100 cm tapered micro-catheter


Locations(2)

University of Miami

Miami, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

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NCT03138863


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