Actively Recruiting
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
Led by Mauro H. Schenone · Updated on 2026-03-19
20
Participants Needed
1
Research Sites
865 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
CONDITIONS
Official Title
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy
- Normal fetal karyotype or microarray; FISH results acceptable if patient is over 26 weeks pregnant
- Isolated severe left congenital diaphragmatic hernia with observed-to-expected lung-to-head ratio (O/E LHR) less than 25%
- Gestational age at enrollment before 29 weeks and 6 days
- Pulmonary hypoplasia with ultrasound O/E LHR less than 25% measured between 18 weeks 0 days and 29 weeks 5 days at time of surgery
- Gestational age at FETO procedure between 27 weeks 0 days and 29 weeks 6 days
- Ability to live within 30 minutes of Mayo Clinic, Rochester, and comply with follow-up travel requirements
- Availability of a support person to stay with the patient during pregnancy at Mayo Clinic
- Willingness and ability to provide informed consent
- Completed counseling with maternal-fetal medicine, neonatology, pediatric surgery, genetics, and pediatric ENT specialists
You will not qualify if you...
- Multiple pregnancy (twins or more)
- History of natural rubber latex allergy
- Preterm labor, shortened cervix less than 20 mm at enrollment or within 24 hours of balloon insertion, or uterine anomaly that greatly increases preterm labor risk
- Inability to live within 30 minutes of Mayo Clinic, Rochester, or lack of support person during pregnancy
- Right sided or bilateral congenital diaphragmatic hernia, or isolated left sided CDH with O/E LHR greater than 25%
- Additional significant fetal anomalies or chromosomal abnormalities worsening prognosis
- Maternal health issues preventing fetoscopic surgery
- History of incompetent cervix with or without cerclage
- Known placental problems such as previa, abruption, or accreta at enrollment
- Maternal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting current pregnancy
- Maternal HIV, Hepatitis B, or Hepatitis C infection
- Uterine abnormalities like large or multiple fibroids or mullerian duct anomalies making the procedure unfeasible
- No safe or technically possible fetoscopic route for balloon placement
- Participation in another intervention study affecting maternal or fetal outcomes or previous participation in this trial during a prior pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
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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