NCT02530073

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Connecticut Children's Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Detailed description

Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio \< 25%(O/E LHR \< 25%).

Conditions

• Congenital Diaphragmatic Hernias

Interventions

Type	Name	Description
DEVICE	Fetoscopic Endoluminal Tracheal Occlusion (FETO)	This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio \<25% (O/E LHR).

Timeline

• Start date: 2015-09-01
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2015-08-20
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study