Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

Oregon Health & Science University (OHSU)

Status and phase: Not yet enrolling; Phase 3

Conditions: Congenital Diaphragmatic Hernia

Treatments: Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06946576

OHSU IRB 27320

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).

Full description

This is an un-blinded, non-randomized, double-arm phase III clinical trial designed to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion in cases of severe Congenital Diaphragmatic Hernia (CDH) and intrathoracic liver herniation. Patients in the intervention arm will undergo balloon insertion into the fetal trachea between 27 and 30 weeks of gestation. Fetoscopic removal of the balloon occlusion will be performed at 34 weeks gestation.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant person age 18 years or older
• Singleton pregnancy
• Normal fetal karyotype with confirmation by culture results, Chromosomal Microarray (CMA) with non-pathological variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by florescence in situ hybridization (FISH) will be acceptable if the patient is >26 weeks gestation
• Gestational age at enrollment less than 29 weeks 6 days
• Intrathoracic liver herniation
• Isolated left Congenital Diaphragmatic Hernia (CDH) with Lung to Head Circumference Ratio (LHR) <30% at enrollment OR isolated right CDH with LHR <= 45% at enrollment
• Cervical length by transvaginal ultrasound >= 20 mm within 24 hours of FETO procedure
• Psychosocial criteria
• Able to provide informed consent

Exclusion criteria

• Patient < 18 years of age
• Multi-fetal pregnancy
• History of natural rubber latex allergy
• Preterm labor, cervix shortened (<20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor or placenta previa
• Psychosocial ineligibility precluding consent
• Inability to reside within 30 minutes of OHSU
• Inability to comply with the travel for the follow-up requirements of the trial
• Lack of a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at OHSU.
• Bilateral CDH, isolated left sided CDL with LHR >= 30% or isolated right side CDH with LHR >45% as determined by ultrasound
• No intrathoracic liver herniation
• Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center
• 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) 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
• No safe or technically feasible fetoscopic approach to balloon placement
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Fetal treatment arm

Experimental group

Description:

Cases that will undergo Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure.

Treatment:

Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

Expectant management arm

No Intervention group

Description:

Cases that meet study inclusion criteria but voluntarily decline the Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure. These cases will undergo the standard of clinical care.