Safety and Efficacy of FETO in CDH Phase III

NCT07187206 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: 2025-0362
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Change lung growth on prenatal imaging

  Change in o/eLHR and other prenatal imaging tests

  prenatal period up to 40 weeks gestation

Secondary Outcomes (1)

• Change survival in the severe congenital diaphragmatic hernia subgroup in intervention group

  6 months

Study Arms (2)

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

EXPERIMENTAL

FETO balloon placement/removal

Device: FETO, Fetal Endoluminal Tracheal Occlusion

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

NO INTERVENTION

no intervention standard of care

Interventions

FETO, Fetal Endoluminal Tracheal Occlusion DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: biological female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hypertension, Pulmonary

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; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Foong-Yen Lim, MD

CONTACT

(513) 636-6259; Foong-Yen.Lim@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 22, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): March 1, 2033
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)