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ACTIVE NOT RECRUITING
NCT02549820
NA

Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

Summary

CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2015-07

Completion Date

2027-07

Last Updated

2025-10-29

Healthy Volunteers

No

Interventions

DEVICE

GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Fetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States