Status:
RECRUITING
Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
KARL STORZ Endoscopy-America, Inc.
Conditions:
Congenital Diaphragmatic Hernia
Congenital Abnormalities
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left conge...
Eligibility Criteria
Inclusion
- Pregnant women who are able to consent
- Singleton pregnancy
- Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, whole exome sequencing (WES) or whole genome sequencing (WGS) . Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
- Gestational age at enrollment is prior to 296 wks.
- Intrathoracic liver herniation
- Isolated left CDH with o/e LHR \< 30% at enrollment (180 to 295 wks.) or
- Isolated RCDH with o/e LHR \< 45% at enrollment (180 to 295 wks.)
- Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure
- Patient meets psychosocial criteria
- Informed consent understood
Exclusion
- 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, placenta previa.
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy.
- 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 Johns Hopkins Hospital Center for Fetal Therapy.
- 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 liver herniation into thoracic cavity
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns).
- 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 anomalies such as large or multiple fibroids or Mullerian duct abnormality
- 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
Key Trial Info
Start Date :
June 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07166172
Start Date
June 23 2025
End Date
December 1 2031
Last Update
September 10 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287