NCT03980717View on ClinicalTrials.gov

Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 9, 2019

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Congenital Diaphragmatic Hernia
Interventions
DEVICE

Goldbal Detachable Balloon and delivery microcatheter

Between 28+0/7 - 31+6/7 weeks gestation for severe CDH placement of the detachable balloon. Balloon retrieval will be planned for no later than 36+6/7 weeks at the discretion of the FETO center.

Trial Locations (1)

77030

RECRUITING

Texas Childrens Hospital, Houston

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

lead

Michael A Belfort

OTHER