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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOregon Health and Science University

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

Treatment groups

80 Participants
are divided into 2 treatment groups