NCT05962346

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mauro H. Schenone · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

Conditions

• Congenital Diaphragmatic Hernia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-12-01
• Primary completion: 2043-07-01
• Completion: 2043-07-01
• First posted: 2023-07-27
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study