Safety and Efficacy of FETO in CDH Phase III
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
Eligibility criteria
Qualifiers
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
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 prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
Trial design
Treatments tested in this trial
- FETO, Fetal Endoluminal Tracheal Occlusion
Treatment groups
75 Participants
are divided into 2 treatment groupsLocations
1Cincinnati Children's Hospital Medical Center (CCHMC)45229, CincinnatiOhio, United States
Sponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Source ClinicalTrials.gov