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.
86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 62 interventional studies indexed under Hernias, Diaphragmatic, Congenital.
Browse Hernias, Diaphragmatic, Congenital studies →This is the only study on the registry with Vincent Duron as lead sponsor.
Compared within Hernias, Diaphragmatic, Congenital, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Diaphragmatic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Meets psychosocial criteria
Exclusion Criteria:
Psychosocial ineligibility
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Hernias, Diaphragmatic, Congenital →