RecruitingNCT05450653FETOUpdated Jan 28, 2026

Trial of FETO for Severe Congenital Diaphragmatic Hernia

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

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study summary

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.

Read the detailed description

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.

Conditions studied

Congenital Diaphragmatic Hernia

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Keywords

Hernia, Diaphragmatic, Congenital
Fetal Endoscopic Tracheal Occlusion
Fetoscopic Endoluminal Tracheal Occlusion
Pregnant
Humans
Fetoscopy

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

Provision of signed and dated informed consent form
Pregnant individuals age 18 years and older
Singleton pregnancy
No pathogenic variants on prenatal chromosomal microarray or pathologic findings on karyotype analysis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
Isolated left CDH with severe pulmonary hypoplasia with o/e LHR \</=25% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation) OR Isolated right CDH with severe pulmonary hypoplasia with o/e LHR \</=35% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)
Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information and evaluation of first ultrasound
Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Willingness to reside within 30 minutes of the Chicago Institute for Fetal Health (CIFH) in the time period between the FETO placement procedure and the balloon retrieval procedure and ability to maintain follow up appointments
- Subject has a support person (e.g., spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Lurie Children's
- Willingness to comply with study restrictions on work, exercise, and intercourse
Meets psychosocial criteria

Exclusion criteria

Exclusion Criteria:

Rubber latex allergy
Presence of chromosomal abnormalities or anatomic anomalies that are known to significantly alter survival prognosis (i.e., CDH and congenital heart disease). No cases will be removed post hoc if abnormalities are discovered during post-operative monitoring
History of preterm labor, cervix shortened to ≤20 mm at enrollment or at 24 hours prior to FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor or placenta previa
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
History of incompetent cervix with or without cerclage
Placental abnormalities (previa, abruption, accreta, chorioangioma) 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
There is no safe or technically feasible fetoscopic approach to balloon placement
Participation in another intervention study that influences maternal and fetal morbidity and mortality
Any other condition which, in the opinion of the investigator, would compromise safety, feasibility or impede compliance

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (estimated)

Study arms

Experimental
FETO with GOLDBAL2
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)

Interventions

DeviceFETO 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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611, United States
- Aimen Shaaban, MD · Contact · Ashaaban@luriechildrens.org · 312-227-4747
Recruiting

References and documents

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT05450653
Lead sponsor: Aimen F. Shaaban, MD
Responsible party: Aimen F. Shaaban, MD (Director, Chicago Institute for Fetal Health, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago) — Sponsor-investigator
First posted: Jul 11, 2022
Start date: Sep 18, 2022
Primary completion: Sep 2030 (estimated)
Completion: Nov 2031 (estimated)
Last update: Jan 28, 2026

Study contacts

Aimen Shaaban, MD

Contact

AShaaban@luriechildrens.org

312-227-4747

Aimen Shaaban, MD

principal investigator · Ann & Robert H Lurie Children's Hospital of Chicago

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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