Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia

NCT06281717 | Withdrawn DMC FDA Device

• 1 other identifier: IRB-P00045047
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth. This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.

Conditions

Congenital Diaphragmatic Hernia

Keywords

Hernias, Diaphragmatic, Congenital; Fetoscopic Endoluminal Tracheal Occlusion; Fetal Endoscopic Tracheal Occlusion; Hernia

Outcome Measures

Primary Outcomes (7)

• Successful Ballon Placement

  Defined as direct visualization of balloon deployment above the carina at the time of FETO procedure

  Gestational age of 27 weeks 0 days to 29 weeks 6 days

• Successful Balloon Removal

  Removal of the balloon prior to delivery, ideally during 34 weeks gestation

  Prior to delivery, ideally at 34 weeks

• Balloon placement operative time

  Length of FETO procedure for successful balloon placement

  Gestational age of 27 weeks 0 days to 29 weeks 6 days

• Balloon removal operative time

  Length of FETO procedure for successful balloon removal

  Prior to delivery, ideally at 34 weeks

• Type of FETO release

  Emergent or non-emergent FETO release

  Prior to delivery, ideally at 34 weeks

• Maternal Complications

  Maternal complications include: preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

  From balloon placement to delivery

• Gestational age at delivery

  Gestational age at delivery will be recorded

  At delivery

Secondary Outcomes (17)

• Fetal lung volume

  Once per week from balloon placement to removal. This measure will be recorded at earliest gestational age of 27 weeks 0 days, and latest at 34+6/7 weeks' gestation.

• Observed-to-Expected Lung to Head Ratio

  Calculated at balloon removal, ideally at 34 weeks gestation

• Infant survival

  At hospital discharge or 6 months of age, whichever comes first. Hospital discharge typically occurs at 2-3 months of age

• Oxygen dependency

  At time of discharge, on average at 2-3 months of age

• Number of infants requiring ECMO (extracorporeal membrane oxygenation)

  Birth to 6 months

Study Arms (1)

Fetal Endotracheal Occlusion (FETO)

EXPERIMENTAL

Participants with severe congenital diaphragmatic hernia will undergo the FETO therapy.

Device: Fetal Endotracheal Occlusion (FETO)

Interventions

Fetal Endotracheal Occlusion (FETO) DEVICE

The FETO insertion procedure will be performed between gestational age 27 weeks 0 days and 29 weeks and 6 days. The Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus using the Delivery Microcatheter (BALTACCI-BDPE100). The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.

Also known as: Fetoscopic Endoluminal Tracheal Occlusion, FETO, Fetal Tracheal Occlusion, BALT GOLDBALLOON: GoldBAL2

Fetal Endotracheal Occlusion (FETO)

Eligibility Criteria

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

You may qualify if:

• Pregnant patient 18 and older who is able to consent
• Singleton pregnancy
• Ability to reside within 30 minutes of Boston Children's Hospital for the duration of the FETO intervention, from the time of balloon placement until balloon removal
• Patient has a support person who is able to stay with them for the duration of the pregnancy
• Fetal:
• Reassuring genetic analysis demonstrated by either normal Karyotype, normal fluorescence in situ hybridization (FISH) for chromosomes 13, 18, 21, X and Y, or chromosomal microarray (CMA) with non-pathologic variants
• Diagnosis of isolated left CDH with liver up
• Gestation at enrollment prior to 29 weeks 5 days
• SEVERE pulmonary hypoplasia with ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25%

You may not qualify if:

• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• Technical limitations precluding fetoscopic surgery, including uterine anomaly such as large or multiple fibroids, or Mullerian duct anomaly
• Latex allergy
• Preterm labor, shortened cervix (\<20mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• Severe maternal obesity pre-pregnancy (BMI \> 40)
• Psychosocial ineligibility, precluding consent, as determined by clinic social worker during review
• Inability to remain at FETO site during time period of tracheal occlusion, delivery, and postnatal care
• Right-sided or bilateral, left-sided CDH observed-to-expected lung to head ratio \> 25% on ultrasound
• Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis
• History of incompetent cervix with or without cerclage
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• Maternal-fetal RH (rhesus) isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• Maternal HIV, Hepatitis B, Hepatitis C status positive

Sponsors & Collaborators

• Eyal Krispin: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

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MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hernia

Condition Hierarchy (Ancestors)

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

Study Officials

• Alireza Shamshirsaz, MD

  Director, Maternal Fetal Care Center

  PRINCIPAL INVESTIGATOR

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: Interim Director, Fetal Care and Surgery Center

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: February 28, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 28, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)