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Pilot Trial of FETO for Severe Left Congenital Diaphragmatic Hernia

This pilot study is testing a surgery called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies with severe left Congenital Diaphragmatic Hernia (CDH) before they are born. CDH is a condition where a baby's diaphragm (the muscle that helps with breathing) doesn't form completely, which can affect lung growth. The FETO surgery involves placing a balloon in the baby's windpipe between 27 and 29 weeks of pregnancy to help their lungs grow. The balloon is then removed between 34 and 34.5 weeks. The main goal is to see how effectively the balloon can be placed. You may be able to join if you are pregnant, at least 18 years old, carrying one baby with a normal genetic test, and your baby has severe left CDH with liver up. The study plans to enroll 10 participants.

Study design
This is an interventional pilot study, meaning it tests a specific treatment. It plans to enroll 10 participants.
What's involved
Participants would undergo Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery between 27 and 29 weeks of gestation, followed by balloon removal between 34 and 34.5 weeks of gestation.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, effective balloon placement, is measured between 27 and 29 weeks gestation.

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NCT04583644

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Recruiting
NAAges 18+InterventionalTreatment
Hanmin Lee
~10 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Fetoscopic Endoluminal Tracheal Occlusion Surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of effective placements of balloon to occlude trachea via fetoscopy
Measured over Between 27 and 29 weeks gestation

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Hanmin Lee, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Katie Archbold, BA
[email protected]
415-476-0445
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pregnant women age 18 years and older
Singleton pregnancy
Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
Isolated Left CDH with liver up
Gestation age at enrollment prior to 29 wks plus 6 days
SEVERE pulmonary hypoplasia with US LHR O/E \< 25% (measured at 180 to 295 weeks) at the time of surgery
Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
Family meets psychosocial criteria
Pre-authorization from third-party payor for fetal intervention OR the ability to self-pay for study treatment. For all patients without insurance or the means to pay for the procedure, an attempt will be made to obtain Medicaid. Insurers that have denied payment have noted that this remains an experimental procedure. As this is a feasibility study and not being offered as either standard of care or as a prospective randomized control trial to determine efficacy, the investigators do not feel that there is a breach of ethical standards.
Informed consent
Patient \< 18 years of age
Multi-fetal pregnancy
Rubber latex allergy
Preterm labor, cervix shortened (\< 15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa

Exclusion

Right sided CDH or bilateral CDH, isolated left sided with LHR O/E \< 25% (measured at 180 to 295 weeks) as determined by ultrasound
Additional fetal anomaly by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
History of incompetent cervix with or without cerclage
Placental abnormalities (previa, abruption, accrete) known at time of enrollment
Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
There is no safe or technically feasible fetoscopic approach to balloon placement
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

What this trial measures

  • Number of effective placements of balloon to occlude trachea via fetoscopyBetween 27 and 29 weeks gestation

    Number of effective placements of balloon to occlude trachea via fetoscopy by performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) in fetuses with severe left congenital diaphragmatic hernia (CDH), as defined by lung to head ratio (LHR) Observed/Expected \< 25%