North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

NCT07564297 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 25-007786
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (2)

• Number of FETO procedure complications

  FETO procedure complications are defined as device dislodgement, intraoperative injury to fetus, procedural hemorrhage, post-procedural hemorrhage, preterm delivery, chorioamnion separation, chorioamnionitis, polyhydramnios, oligohydramnios, failed percutaneous or fetoscopic removal requiring cesarean section or EXIT procedure for removal, neonatal death due to asphyxia (if delivery before FETO removal), non-reassuring fetal heart rate monitoring.

  2 years

• Neonatal survival to discharge

  Number of neonates to survive from delivery to hospital discharge

  2 years

Secondary Outcomes (12)

• Presence of pulmonary hypertension

  6, 12, 18, and 24 months of age

• Need for supplemental oxygen

  6, 12, 18, and 24 months of age

• Periventricular leukomalacia at < 2 months postnatally

  2 months

• Intraventricular hemorrhage (grade 0-III)

  6, 12, 18, and 24 months of age

• Retinopathy of prematurity (grade 3 or higher)

  6, 12, 18, and 24 months of age

Study Arms (2)

FETO Surgery

Device: Fetoscopic Endoluminal Tracheal Occlusion

Standard of Care

Other: Standard of Care

Interventions

Fetoscopic Endoluminal Tracheal Occlusion DEVICE

Mothers who chose to undergo a Fetoscopic Endoluminal Tracheal Occlusion procedure for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age.

FETO Surgery

Standard of Care OTHER

Mothers who chose to receive expectant management for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients with fetuses affected by congenital diaphragmatic hernia meeting the inclusion criteria above-mentioned and not meeting exclusion criteria.

You may qualify if:

• Singleton pregnancy
• 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
• Gestational age at enrollment prior to 29 6/7 weeks
• Intrathoracic liver herniation Isolated left CDH with O/E LHR \< 30% at enrollment (18 0/7 to 29 5/7 weeks.) Isolated right CDH with O/E LHR \< 45% at enrollment (18 0/7 to 29 5/7 weeks).
• Cervical length by transvaginal ultrasound \> 20 mm within 24 to 48 hours prior to FETO procedure
• Patient meets psychosocial criteria
• Informed consent understood

You may not qualify if:

• Multi-fetal pregnancy
• History of natural rubber latex allergy
• Preterm labor, cervix shortened (\<20 mm at enrollment or within 24 to 48 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• Psychosocial ineligibility, precluding consent:
• Inability to reside within 30 minutes of Mayo Clinic. and inability to comply with the travel for the follow-up requirements of the trial
• 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 Mayo Clinic.
• Bilateral CDH, isolated left sided CDH with O/E LHR 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR \> 45% (measured at 180 to 295 weeks), 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mauro Schenone, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OB/GYN Clinical Research Team

CONTACT

507-266-3382

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2036
• Study Completion (Estimated): May 31, 2038
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)