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

NCT ID: NCT06946576

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2030-04-30

Brief Summary

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).

Detailed 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.

Conditions

Congenital Diaphragmatic Hernia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fetal treatment arm

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

Group Type: EXPERIMENTAL

Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

Intervention Type: DEVICE

FETO procedure involves insertion of a balloon into the fetal trachea under IV sedation with local anesthesia or combined spinal-epidural anesthesia. Balloon removal will take place up to 7 weeks after insertion.

Expectant management arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

FETO procedure involves insertion of a balloon into the fetal trachea under IV sedation with local anesthesia or combined spinal-epidural anesthesia. Balloon removal will take place up to 7 weeks after insertion.

Intervention Type: DEVICE

Other Intervention Names

FETO; GoldBAL2 Detachable Balloon

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Raphael Sun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raphael Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Andrew Chon, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Central Contacts

Women's Health Research Unit Department of Ob/Gyn

Role: CONTACT

whru@ohsu.edu

503-494-3666

Other Identifiers

STUDY00027320

Identifier Type: -

Identifier Source: org_study_id