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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
FETO, Fetal Endoluminal Tracheal Occlusion
DeviceFetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occluExperimental treatment 1 intervention
Group B: Fetuses with severe or moderate congenital diaphragmatic hernia will receive standard of care and opNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change lung growth on prenatal imaging
Change in o/eLHR and other prenatal imaging tests
Time frame
prenatal period up to 40 weeks gestationSecondary outcomes
1
Change survival in the severe congenital diaphragmatic hernia subgroup in intervention group
change rate of survival
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov