NCT00881660: FETO

Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia

Completed NA Last updated 14 November 2025

What this trial tests

NA trial testing Goldballoon Detachable Balloon and delivery microcatheter in Congenital Diaphragmatic Hernia in 20 participants. Completed in 11 April 2023.

Timeline

21 February 2012

Primary endpoint
11 April 2023

11 April 2023

Quick facts

Lead sponsor	Michael A Belfort
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	20
Start date	21 February 2012
Primary completion	11 April 2023
Estimated completion	11 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Goldballoon Detachable Balloon and delivery microcatheter

Conditions studied

• Congenital Diaphragmatic Hernia — all drugs for Congenital Diaphragmatic Hernia →

Sponsor

Michael A Belfort

Who can join

Adults 18 to 45, female only, with Congenital Diaphragmatic Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.

Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to demonstrate the feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug procedure will improve mortality and morbidity outcomes as compared with current management, but this is not a primary endpoint of the feasibility study. We will perform 20 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Polygenic Causes of Congenital Diaphragmatic Hernia Produce Common Lung Pathologies.
   Donahoe PK, Longoni M, High FA. · · 2016 · cited 61× · PMID 27565037 · DOI 10.1016/j.ajpath.2016.07.006
2. Feasibility and Outcomes of Fetoscopic Tracheal Occlusion for Severe Left Diaphragmatic Hernia.
   Belfort MA, Olutoye OO, Cass DL, Olutoye OA, et al · · 2017 · cited 51× · PMID 27926636 · DOI 10.1097/aog.0000000000001749