Safety and Efficacy of FETO in CDH Phase III

NCT ID: NCT07187206

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2033-03-01

Brief Summary

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Detailed Description

The purpose of this study is to demonstrate that the FETO procedure increases the neonatal survival to discharge and reduces long-term morbidity rates in fetuses found to have intrathoracic herniation of the liver with LCDH and o/e LHR < 30% or RCDH and o/e LHR < 45 % with intrathoracic liver herniation when compared to those that receive standard of care management that have comparable defects for side and fetal lung volumes estimates and intrathoracic liver herniation.

Conditions

Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia; Pulmonary Hypertension

Study Design

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

Study Groups

Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlu

FETO balloon placement/removal

Group Type: EXPERIMENTAL

FETO, Fetal Endoluminal Tracheal Occlusion

Intervention Type: DEVICE

Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia

Fetuses with severe or moderate congenital diaphragmatic hernia will receive standard of care and op

no intervention standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FETO, Fetal Endoluminal Tracheal Occlusion

Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pregnant women 18 years and older, who are able to consent
• Singleton pregnancy
• Gestational age at enrollment is prior to 296 weeks
• Intrathoracic liver herniation
• Isolated Left CDH with o/e LHR < 30% at enrollment (180 to 295 weeks) or
• Isolated Right CDH with o/e LHR < 45% at enrollment (180 to 295 weeks)
• Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
• Cervical length by transvaginal ultrasound > 20 mm within 24 hours prior to FETO procedure
• Patient meets psychosocial criteria
• Informed consent understood

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 prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
• Psychosocial ineligibility, precluding consent:

• Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.
• The patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Cincinnati Children's Hospital Medical Center.
• Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR > 45%, as determined by ultrasound.
• No liver herniation into thoracic cavity
• 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 positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.
• Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure
• 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, or participation in this trial in a previous pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Foong-Yen Lim, MD

Role: CONTACT

Foong-Yen.Lim@cchmc.org

(513) 636-6259

Facility Contacts

Foong-Yen Lim

Role: primary

foong.yen.lim@cchmc.org

513-803-5270

Erin Watters

Role: backup

erin.watters@cchmc.org

513-803-7024

Other Identifiers

2025-0362

Identifier Type: -

Identifier Source: org_study_id