An interventional study of FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) in Congenital Diaphragmatic Hernia, sponsored by Aimen F. Shaaban, MD. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Aimen F. Shaaban, MD · Not applicable, Interventional, and Treatment
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.
A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100) between 27 weeks 0 days and 29 weeks and 6 days of gestation. The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days of gestation or earlier as indicated.
After balloon insertion, participants will be followed weekly and must reside within 30 minutes of Lurie Children's until balloon removal. Additionally, participants will have restrictions from return to work, exercise, or intercourse. The children's health status will be followed until two years of age.
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 Aimen F. Shaaban, MD as lead sponsor.
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Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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.
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.
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.
A detachable balloon will be inserted in the fetal airway during the FETO procedure.
Device: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus with severe congenital diaphragmatic hernia (o/e LHR \<25% with liver up) during the FETO procedure between gestational age 27 weeks 0 days and 29 weeks and 6 days. The fetal tracheal balloon will be removed at between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.
Number of successful placements of Goldballoon Detachable Balloon at gestational age 27 weeks 0 days (27w0d) to 29 weeks 6 days (29w6d)
Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure.
Time frame: 27 weeks zero days to 29 weeks 6 days
Number of successful removals of balloon
Removal of the balloon will ideally be done at 34th week of gestation or prior to delivery.
Time frame: Removal prior to delivery, ideally at 34 weeks gestation
Change in fetal lung growth
Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal.
Time frame: Baseline (before balloon placement) to first ultrasound after balloon removal
Gestational age at delivery
Gestational age at delivery will be recorded.
Time frame: At the time of delivery
Infant survival
Infant survival will be measured from delivery to discharge, at 6, 12, and 24 months of age.
Time frame: Birth to 24 months
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Use of ECMO will be collected from medical chart review.
Time frame: Birth to 6 months
Number of infants with sepsis
Sepsis occurrences will be collected from medical chart review.
Time frame: Birth to six months
Number of infants with intraventricular hemorrhage (IVH)
Intraventricular hemorrhage data will be collected from medical chart review.
Time frame: Birth to six months
Length of hospital stay
Hospital length of stay will be calculated from medical chart review.
Time frame: Birth to one year
Number of infants requiring supplemental oxygen
Supplemental oxygen requirement at time of discharge will be collected from medical chart review.
Time frame: Birth to 24 months
Number of maternal complications
Complications during pregnancy, delivery, and first post-partum visit to include: preterm labor, premature rupture of membranes (PROM), preterm premature rupture of membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamnionitis, and other infection.
Time frame: Up to 4-6 weeks post-partum
Plan to share: No
Started Sep 2022 (actual). Primary completion is estimated for Sep 2030, 96 months after the start.
Of 40 interventional studies with no phase under Hernias, Diaphragmatic, Congenital, half reached primary completion within 108 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 133. This study's planned 96 months is below that.
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Hernias, Diaphragmatic, Congenital →