An interventional study of Placement of the GOLDBAL2 balloon in Diaphragmatic Hernia, sponsored by Vincent Duron. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Vincent Duron · Not applicable, Interventional, and Treatment
This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).
Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year. The defect in the fetal diaphragm allows abdominal organs (intestine, stomach, liver, spleen) to migrate into the thorax, hindering normal lung development. The herniated contents place pressure on the developing lungs and this may result in varying degrees of pulmonary hypoplasia and associated pulmonary hypertension; both of which may be lethal. In an attempt to prenatally quantify the impact of the herniated organs on underlying lung development, prognostic tools have been developed. The most widely used prognostic indicator is lung-to-head ratio (LHR) as measured by prenatal ultrasound. The lung contralateral to the diaphragmatic defect is measured in a transverse plane at the level of the four chamber heart and its area is divided by the fetal head circumference (LHR). The LHR is tracked through the pregnancy but seems to be most strongly correlated with outcomes in the early third trimester.
Fetuses with severe CDH have a high risk of mortality. The current standard of care treatment offers postnatal repair, which is associated with overall survival of 71% in all cases. A majority (68%) of fetuses are prenatally diagnosed, and the survival in this cohort is even lower at 65%. The severity of the defect can be measured prenatally by the degree of pulmonary hypoplasia, and the survival drops to below 30% for those with expected lung volumes below 30% of expected. The purpose of the FETO procedure in severe CDH patients is to improve prenatal lung growth in order to potentially increase neonatal survival.
Meets psychosocial criteria
Exclusion Criteria:
Psychosocial ineligibility
GOLDBAL2 balloon will be placed for Fetus diagnosed with Congenital diaphragmatic hernia (CDH) at Gestational age of 27w0d - 29w6d and retrieved at Gestational age of 34w0d to 34w 6 days
Device: Placement of the GOLDBAL2 balloon
The Fetal Endoscopic Tracheal Occlusion (FETO) procedure using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) will be used to treat fetuses diagnosed with severe Congenital Diaphragmatic Hernia (CDH)
Total number of subjects with successful placement of the balloon
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Time frame: Up to 30 weeks
Total number of subjects with successful retrieval of the balloon
Success will be defined by retrieval prior to delivery, including safe retrieval during an ex-utero intrapartum therapy (EXIT) procedure.
Time frame: Up to 35 weeks
Change in fetal lung volume growth on prenatal MRI
Fetal MRI prior to balloon placement and 2nd fetal MRI at +/- 2 weeks of balloon retrieval will be performed to calculate the difference between the 1st and 2nd MRIs.
Time frame: Baseline and up to 37 weeks
Change in fetal lung growth on prenatal ultrasound
Fetal ultrasound before balloon placement and immediately prior to balloon removal will be performed to calculate the different between the 2 ultrasounds.
Time frame: Baseline and up to 35 weeks
Gestational age at delivery
Gestational age at delivery will be measured.
Time frame: At the time of delivery (up to 40 weeks of gestation)
Total number of maternal complications
Maternal complications will be recorded and reviewed.
Time frame: Up to 6 weeks post-delivery
Survival rate post-delivery
Survival rate will be measured at 180 days for those still hospitalized at the time point.
Time frame: Up to 180 days post-delivery
Plan to share: No
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