NCT06281717View on ClinicalTrials.gov

Fetal Endotracheal Occlusion (FETO) in Fetuses with Severe Congenital Diaphragmatic Hernia

NANot yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

September 1, 2027

Study Completion Date

February 28, 2031

Conditions
Congenital Diaphragmatic Hernia
Interventions
DEVICE

Fetal Endotracheal Occlusion (FETO)

The FETO insertion procedure will be performed between gestational age 27 weeks 0 days and 29 weeks and 6 days. The Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus using the Delivery Microcatheter (BALTACCI-BDPE100). The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.

Trial Locations (1)

02115

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Alireza Shamshirsaz

OTHER

NCT06281717 - Fetal Endotracheal Occlusion (FETO) in Fetuses with Severe Congenital Diaphragmatic Hernia | Biotech Hunter | Biotech Hunter