Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 21, 2012

Primary Completion Date

April 11, 2023

Study Completion Date

April 11, 2023

Conditions
Congenital Diaphragmatic Hernia
Interventions
DEVICE

Goldballoon Detachable Balloon and delivery microcatheter

"Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as extremely severe cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center."

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

lead

Michael A Belfort

OTHER

NCT00881660 - Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia | Biotech Hunter | Biotech Hunter