RecruitingNot ApplicableNCT06884423

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

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

Sponsor

Holly L Hedrick, MD

Enrollment

80 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Congenital Diaphragmatic Hernia Pulmonary Hypoplasia

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter for people with congenital diaphragmatic hernia and pulmonary hypoplasia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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