Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

July 31, 2043

Study Completion Date

July 31, 2043

Conditions
Congenital Diaphragmatic Hernia
Interventions
DEVICE

BALT GOLDBALL 2 detachable latex ballon

Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.

DEVICE

BALTACCIBDPE100 Microcatheter

Used to deliver the detachable balloon

DEVICE

Storz fetoscopic operating sheath and miniature telescope/fetoscope

Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.

Trial Locations (1)

55905

RECRUITING

Mayo Clinic Minnesota, Rochester

All Listed Sponsors
lead

Mauro H. Schenone

OTHER