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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07187206
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