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

NCT06946576 | Not Yet Recruiting Phase 3 DMC FDA Device

• 1 other identifier: STUDY00027320
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Congenital Diaphragmatic Hernia

Keywords

Fetal Surgery; Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Outcome Measures

Primary Outcomes (3)

• Outcomes of placement and removal of FETO device

  Whether placement and removal of the FETO device was successful or not

  Device placement will take place between 27 weeks 0 days and 29 weeks 6 days gestation. Removal will take place between 34 weeks 0 days and 34 weeks 6 days.

• Compare survival to discharge between FETO and expectant management

  Evaluate rates of survival to discharge from the neonatal intensive care units (NICU) between fetuses treated with the FETO and those undergoing expectant management

  Evaluated upon discharge from the NICU (typically 6 months to 1 year after birth)

• FETO Complications

  Evaluate the frequency of maternal and fetal complications associated with the FETO procedure

  Information about adverse events and complications will take place from study enrollment (gestational age less than 29 weeks) to study conclusion (24 months post-birth)

Secondary Outcomes (1)

• Long-term mortality and morbidities

  6 months, 12 months, 18 months, and 24 months of age

Study Arms (2)

Fetal treatment arm

EXPERIMENTAL

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

Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

Expectant management arm

NO INTERVENTION

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.

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure 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.

Also known as: FETO, GoldBAL2 Detachable Balloon

Fetal treatment arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Raphael Sun, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Andrew Chon, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an unblinded trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Unblinded non-randomized double-arm phase III study

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)