NCT05450653View on ClinicalTrials.gov

Trial of FETO for Severe Congenital Diaphragmatic Hernia

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 18, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

November 30, 2027

Conditions
Congenital Diaphragmatic Hernia
Interventions
DEVICE

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)

A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus with severe congenital diaphragmatic hernia (o/e LHR \<25% with liver up) during the FETO procedure between gestational age 27 weeks 0 days and 29 weeks and 6 days. The fetal tracheal balloon will be removed at between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.

Trial Locations (1)

60611

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

All Listed Sponsors
lead

Aimen F. Shaaban, MD

OTHER