NCT06946576

Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

Infant Survival and Long-term Outcomes Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).

Detailed description

This is an un-blinded, non-randomized, double-arm phase III clinical trial designed to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion in cases of severe Congenital Diaphragmatic Hernia (CDH) and intrathoracic liver herniation. Patients in the intervention arm will undergo balloon insertion into the fetal trachea between 27 and 30 weeks of gestation. Fetoscopic removal of the balloon occlusion will be performed at 34 weeks gestation.

Conditions

• Congenital Diaphragmatic Hernia

Interventions

Type	Name	Description
DEVICE	Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure	FETO procedure involves insertion of a balloon into the fetal trachea under IV sedation with local anesthesia or combined spinal-epidural anesthesia. Balloon removal will take place up to 7 weeks after insertion.

Timeline

• Start date: 2025-09-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2025-04-27
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study