Safety and Efficacy of FETO in CDH: A Phase III Trial

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

April 30, 2030

Study Completion Date

April 30, 2032

Conditions
Congenital Diaphragmatic HerniaPulmonary Hypoplasia
Interventions
DEVICE

FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter

Fetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Trial Locations (2)

19104

NOT_YET_RECRUITING

Children's Hospital of Philadelphia, Philadelphia

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
lead

Holly L Hedrick, MD

OTHER