Actively Recruiting
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
Led by Vincent Duron · Updated on 2025-11-05
10
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).
CONDITIONS
Official Title
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Pregnant women aged 18 years and older
- Singleton pregnancy
- No pathogenic variants on microarray or pathologic findings on karyotype; FISH results acceptable if >26 weeks
- Fetal echocardiogram showing changes expected with CDH and no major structural heart defects
- Fetal CDH with severe pulmonary hypoplasia, defined as observed/expected lung-to-head ratio (o/e LHR) less than 25% with liver herniation
- Gestational age at FETO procedure between 27 weeks 0 days and 29 weeks 6 days if o/e LHR <25%
- Meets psychosocial criteria including willingness to reside within 30 minutes of study hospital, ability to maintain follow-up appointments, having a support person, and compliance with daily living restrictions
You will not qualify if you...
- Multi-fetal pregnancy
- History of latex allergy
- History of preterm labor, incompetent cervix requiring cerclage, short cervix (<20mm), or uterine anomaly predisposing to preterm labor
- Psychosocial ineligibility including inability to reside within 30 minutes of study hospital or maintain follow-up
- Bilateral CDH, unilateral CDH with o/e LHR greater than 25%, or unilateral CDH with o/e LHR less than 25% but liver fully in abdomen
- Additional fetal or genetic abnormalities impacting post-delivery care or outcome
- Maternal contraindications to elective fetoscopic surgery
- Significant placental abnormalities known at enrollment or surgery
- Maternal-fetal Rh isoimmunization, Kell sensitization, neonatal alloimmune thrombocytopenia affecting current pregnancy, or maternal HIV, Hepatitis B or C with virus presence
- No safe or feasible fetoscopic approach to balloon placement
- Uterine anomalies such as large or multiple fibroids or mullerian duct abnormality
- Participation in another intervention study affecting maternal or fetal outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center/NewYork-Presbyterian
New York, New York, United States, 11021
Actively Recruiting
Research Team
A
Amanda Alonso, MHA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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