RecruitingPhase 3NCT07187206

Safety and Efficacy of FETO in CDH Phase III


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

75 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing a fetal procedure called FETO (Fetal Endoscopic Tracheal Occlusion) — where a tiny balloon is placed in a baby's windpipe before birth — to improve survival in babies with severe congenital diaphragmatic hernia (CDH), a condition where the diaphragm doesn't fully close and organs push into the chest, preventing the lungs from developing normally. **You may be eligible if...** - You are a pregnant woman aged 18 or older with a singleton pregnancy - Your baby has been diagnosed with severe left or right-sided CDH with liver in the chest - The baby's lung-to-head ratio is below the required threshold for this procedure - The baby has normal chromosomes and no other structural abnormalities - Your cervix is long enough and you can reside within 30 minutes of the treating hospital **You may NOT be eligible if...** - You are carrying twins or more - You have latex allergy, preterm labor, or short cervix - Your baby has bilateral CDH or other significant abnormalities - You cannot have a support person stay with you for the duration of the pregnancy at the hospital 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

DEVICEFETO, Fetal Endoluminal Tracheal Occlusion

Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia


Locations(1)

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, United States

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NCT07187206


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