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RECRUITING
NCT06884423
NA

Safety and Efficacy of FETO in CDH: A Phase III Trial

Sponsor: Holly L Hedrick, MD

View on ClinicalTrials.gov

Summary

Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, 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: Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-04-07

Completion Date

2032-04

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

DEVICE

FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter

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

Locations (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States