Trial of FETO for Severe Congenital Diaphragmatic Hernia

NCT05450653 | Recruiting FDA Device

• 1 other identifier: 2021-4085
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Diaphragmatic Hernia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Removal prior to delivery, ideally at 34 weeks gestation

Secondary Outcomes (9)

• Change in fetal lung growth

  Baseline (before balloon placement) to first ultrasound after balloon removal

• Gestational age at delivery

  At the time of delivery

• Infant survival

  Birth to 24 months

• Number of infants requiring extra corporeal membrane oxygenation (ECMO) support

  Birth to 6 months

• Number of infants with sepsis

  Birth to six months

Study Arms (1)

FETO with GOLDBAL2

EXPERIMENTAL

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

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) DEVICE

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.

FETO with GOLDBAL2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aimen F. Shaaban, MD: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Related Links

• MedlinePlus Genetics: Congenital diaphragmatic hernia
• Genetic and rare diseases information resources: Congenital Diaphragmatic Hernia
• U.S. FDA Resources
• Hernia

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Aimen Shaaban, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimen Shaaban, MD

CONTACT

312-227-4747; AShaaban@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Chicago Institute for Fetal Health, Principal Investigator

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 11, 2022
• Study Start: September 18, 2022
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): November 1, 2031
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)