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FETO for Severe Congenital Diaphragmatic Hernia

This study is looking at a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies with severe Congenital Diaphragmatic Hernia (CDH). CDH is a condition where a hole in the baby's diaphragm (the muscle that separates the chest and belly) allows organs to move into the chest, limiting lung growth. The FETO procedure involves placing a balloon-like device in the baby's airway while still in the womb. This balloon helps fluid build up, which can encourage the baby's lungs to grow larger. Researchers want to see if placing and removing this device, called the Balt Goldbal2 balloon, is safe and effective for babies with very severe left or right CDH. The study aims to enroll 10 pregnant women and is currently unclear on its recruitment status.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
What's involved
You would need to be pregnant, 18 years or older, and have a singleton pregnancy. Your baby would need a diagnosis of isolated left or right CDH with liver up, and severe pulmonary hypoplasia. The FETO procedure involves placing and removing a balloon device.
Compensation
Not stated in the trial record.
Follow-up
The study measures successful balloon placement 7 weeks after placement, successful balloon removal within 5 weeks prior to delivery, and gestational age at delivery.

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NCT03674372

Fetoscopic Endoluminal Tracheal Occlusion

Recruiting
NAAges 18+InterventionalTreatment
University of Colorado, Denver
~10 participants
Updated 2025-06-10 on ClinicalTrials.gov
What's tested:Fetoscopic Endoluminal Tracheal Occlusion (FETO)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful placement of Balt Goldbal2 balloon
Measured over 7 weeks after placement
+3 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Colorado1

Who to contact

Elizabeth Torres
[email protected]
720-777-1661
Email the study team

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Eligibility criteria

Inclusion

Pregnant women age 18 years and older, who are able to consent
Singleton pregnancy
Normal Karyotype
Fetal Diagnosis of Isolated Left or Right CDH with liver up
Gestation at enrollment prior to 29 wks plus 6 days
SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR \< 25% or R-sided O/E LHR \<45%

Exclusion

Pregnant women \<18 years of age.
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Technical limitations precluding fetoscopic surgery
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
Psychosocial ineligibility, precluding consent
Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

What this trial measures

  • Successful placement of Balt Goldbal2 balloon7 weeks after placement

    The feasibility of performing the procedure and managing the pregnancy during the period of tracheal occlusion

  • Successful removal of Balt Goldbal2 balloonWithin 5 weeks prior to delivery

    The feasibility of the removal of the device prior to delivery

  • Gestational age at deliveryAt delivery
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)

    Incidence of Maternal complications: preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis)