Actively Recruiting
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia
Led by Mauro H. Schenone · Updated on 2026-03-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for fetuses diagnosed with severe left congenital diaphragmatic hernia (CDH). This research is conducted at Mayo Clinic and aims to improve lung development in affected fetuses by using a special balloon device. The study focuses on a specific group of pregnant women carrying single fetuses with severe lung underdevelopment as measured by ultrasound lung-to-head ratio. Participants will undergo the FETO procedure between 27 weeks 0 days and 29 weeks 6 days of pregnancy. This involves placing a detachable latex balloon inside the fetal trachea using a fetoscopic device inserted through the mother's abdomen and uterus. The balloon is inflated to block the trachea, which is intended to help promote lung growth. The study tracks the success of balloon placement and removal, surgery times, and any unplanned balloon removals or maternal complications. During the study, researchers will monitor the pregnancy until delivery and assess various outcomes including gestational age at delivery and maternal complications. After birth, infants will be followed up to 24 months to measure lung growth, survival, oxygen dependency, complications, and time spent in neonatal intensive care or on ventilators. Maternal hospitalization and delivery methods are also recorded. Participants will need to comply with follow-up requirements and live near Mayo Clinic during the pregnancy for close monitoring.
CONDITIONS
Brief 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 acceptable if > 26 weeks)
- 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 6 days
- Pulmonary hypoplasia confirmed by ultrasound O/E LHR < 25% measured between 18 0/7 and 29 5/7 weeks
- Gestational age at FETO procedure between 27 weeks 0 days and 29 weeks 6 days
- Ability to reside within 30 minutes of Mayo Clinic and comply with follow-up travel requirements
- Availability of a support person to stay with the patient during pregnancy
- Willingness and ability to give informed consent
- Multidisciplinary counseling completed with relevant specialists
You will not qualify if you...
- Multifetal pregnancy
- History of natural rubber latex allergy
- Preterm labor or cervix length under 20 mm at enrollment or within 24 hours of balloon insertion
- Uterine anomaly strongly predisposing to preterm labor
- Psychosocial ineligibility including inability to reside near Mayo Clinic or lack of support person
- Right sided or bilateral congenital diaphragmatic hernia, or left sided with O/E LHR above 25%
- Additional fetal anomalies or chromosomal abnormalities worsening prognosis
- Maternal contraindications to fetoscopic surgery
- History of incompetent cervix with or without cerclage
- Known placental abnormalities at enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting pregnancy
- Maternal HIV, Hepatitis-B, or Hepatitis-C positive status
- Uterine anomalies making procedure unfeasible
- No safe or technically feasible fetoscopic approach for balloon placement
- Participation in another intervention study affecting maternal or fetal outcomes or previous participation in this trial during another pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks before 29 weeks 6 days gestation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Between 27 weeks 0 days and 29 weeks 6 days gestation
Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure to place a detachable balloon in the fetal trachea to promote lung growth.
1 surgical procedure visit and immediate post-operative monitoring
Duration - Up to 41 weeks gestation
Participants are monitored for balloon retrieval and maternal and fetal health until delivery.
Visits as needed for balloon retrieval and maternal/fetal assessments until delivery
Duration - Up to 24 months post partum
Participants and infants are monitored for growth, survival, and complications up to 24 months post partum.
Periodic follow-up visits for infant and maternal health assessments
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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