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FETO for Congenital Diaphragmatic Hernia

This study is looking into the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies diagnosed with Congenital Diaphragmatic Hernia (CDH). CDH is a condition where a baby's diaphragm (the muscle that separates the chest from the abdomen) doesn't form completely, which can lead to problems with lung development (Pulmonary Hypoplasia) and high blood pressure in the lungs (Pulmonary Artery Hypertension). The FETO procedure uses a BALT GoldbBAL2 Detachable Balloon and a Catheter System. Researchers want to see how many FETO procedures are successfully completed, how long they take, and if the balloon needs to be removed unexpectedly. This study is for women aged 18 to 50 who are pregnant with a single baby, have a normal fetal karyotype (chromosome test), and whose baby has isolated left CDH with the liver in the chest, and severe pulmonary hypoplasia before 29 weeks and 6 days of pregnancy. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is designed to gather information on the safety and effectiveness of the FETO procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured up to 34 weeks gestation.

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NCT03138863

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Recruiting
NAAges 18–50InterventionalTreatment
Rodrigo Ruano
~10 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:BALT GoldbBAL2 Detachable BalloonCatheter System

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of successfully completed FETO procedures
Measured over Up to 34 weeks gestation
+5 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia
Pulmonary Hypoplasia
Pulmonary Artery Hypertension

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

2 sites across 2 states
Florida1
Minnesota1

Study leadership

  • Rodrigo Ruano, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Rodrigo A Ruano, MD, Ph.D
[email protected]
305.689.8001
Email the study team

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Eligibility criteria

Inclusion

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 ultrasound (US) O/E lung area to head circumference ratio (LHR) \< 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to \<30% (measured at 300 to 316 weeks) at time of surgery.
Gestational age at FETO procedure with O/E LHR \<25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to \<30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
Patient meets psychosocial criteria

Exclusion

Multi-fetal pregnancy
History of natural 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 reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative 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
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 successfully completed FETO proceduresUp to 34 weeks gestation

    The number of successful placement and removal of balloon during FETO procedure

  • Operative timeUp to 34 weeks gestation

    FETO placement and release operative times reported in minutes

  • Frequency of unplanned balloon removalUp to 34 weeks gestation

    The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)

  • Number of incidences of maternal complicationsUp to 41 weeks gestation

    Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

  • Number of participants with maternal complicationsUp to 41 weeks gestation

    Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

  • Gestational Age at DeliveryUp to 41 weeks gestation

    Gestation Age reported at time of delivery