Actively Recruiting
Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
Led by Yair Blumenfeld · Updated on 2026-01-29
15
Participants Needed
1
Research Sites
384 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.
CONDITIONS
Official Title
Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age between 18 and 50 years
- Singleton pregnancy
- Gestational age less than 29 weeks and 6 days
- Severe left or right-sided congenital diaphragmatic hernia (CDH) with specific lung size and liver herniation criteria
- Normal genetic testing results by amniocentesis or chorionic villus sampling
- No structural heart anomalies confirmed by fetal echocardiogram
- No other structural anomalies detected by ultrasound or MRI
- Completed counseling with maternal-fetal medicine, neonatology, pediatric surgery, genetics, and pediatric ENT specialists
- Willingness to stay within 30 minutes of Lucile Packard Children's Hospital Stanford during balloon placement
- No maternal or fetal contraindications to fetal surgery such as bleeding disorders, poorly controlled diabetes or hypertension, short cervix (<20mm), or risk of preterm birth
- Planned pregnancy monitoring and delivery at Lucile Packard Children's Hospital Stanford
- Ability to provide written consent
- Willingness to comply with all study procedures and have a support person available
You will not qualify if you...
- Contraindications to fetal surgery including poorly controlled hypertension, diabetes, or other maternal medical conditions
- High risk for preterm labor or delivery due to history of preterm birth, short cervix (<20mm), uterine abnormalities, or incompetent cervix
- CDH combined with other structural anomalies (non-isolated CDH)
- Maternal obesity with body mass index (BMI) greater than 40
- History of natural rubber latex allergy
- Uterine anomalies such as large or multiple fibroids or Mullerian duct abnormalities
- Participation in other intervention studies affecting maternal or fetal health
- Bilateral CDH, left-sided CDH with observed-to-expected lung-to-head ratio (o/e LHR) > 25%, or left-sided CDH with o/e LHR < 25% but liver fully in abdomen
- Right-sided CDH with o/e LHR > 30% or with o/e LHR < 30% but liver fully in abdomen
- Significant placental abnormalities known at enrollment
- Maternal-fetal blood incompatibilities affecting the pregnancy
- Maternal infections including HIV, Hepatitis B or Hepatitis C with active virus
- No safe or feasible fetoscopic approach for balloon placement
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital
Stanford, California, United States, 94305-6070
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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