NCT07166172View on ClinicalTrials.gov

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 23, 2025

Primary Completion Date

December 1, 2029

Study Completion Date

December 1, 2031

Conditions
Congenital Diaphragmatic HerniaCongenital AbnormalitiesNeonatal Diseases and AbnormalitiesHernia, DIaphragmatic, CongenitalInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms
Interventions
DEVICE

Fetal Treatment Arm (FETO Group)

Participants will undergo FETO surgery between 27 weeks 0 days to 29 weeks 6 days gestation. The FETO intervention involves two procedures: (1) inserting a balloon into the fetal trachea, and (2) removing the balloon before delivery. After the first FETO procedure, participants will be monitored weekly by ultrasound. Removal of the balloon will be performed at 34 weeks 0 days to 34 weeks 6 days. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age.

Trial Locations (1)

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

Sponsors
All Listed Sponsors
collaborator

KARL STORZ Endoscopy-America, Inc.

INDUSTRY

lead

Johns Hopkins University

OTHER

NCT07166172 - Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH | Biotech Hunter | Biotech Hunter