NCT06884423

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Holly L Hedrick, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients will complete a standard prenatal evaluation at the Children's Hospital of Philadelphia (CHOP) Center for Fetal Diagnosis and Treatment (CFDT) to determine if they are candidates for this study. The standard clinical assessments include medical history and physical exam, level II ultrasound, fetal echocardiogram, fetal magnetic resonance imaging (MRI), and a psychosocial assessment. If determined eligible for fetoscopic endoluminal tracheal occlusion (FETO) intervention, patients will be extensively counseled by the CFDT Team and those who choose to participate will provide written, informed consent for study enrollment. Up to 40 maternal/fetal dyads will be enrolled in the intervention arm of this study. The pregnant patient and fetus will undergo two procedures. A balloon will be placed in the fetal airway between 27+0/7 - 29+6/7 gestational age. The balloon blocks the airway and remains in place until balloon removal. The timing for balloon removal will be determined by the CFDT Management Team and can occur between 34 +0/7 - 34+6/7 gestational age. Pregnant patients enrolled in the intervention arm of study must remain near the fetal center, under close supervision, from the time of balloon placement through delivery in the CHOP Garbose Family Special Delivery Unit. Weekly prenatal monitoring will occur after the first procedure at the CFDT, and planned delivery will occur in the Garbose Family Special Delivery Unit at term. Postnatal stabilization and subsequent surgery to repair the diaphragm will take place at CHOP. Up to 40 maternal/fetal dyads which meet criteria according to defect side, observed/expected lung to head ratio (O/E LHR), and liver position, but undergo expectant management rather than FETO intervention, will be enrolled in the control arm of this study. Infants in both the intervention arm and the control arm will be followed at CHOP at 6 months, 12 months, 18 months, and 24 months of age through the CHOP Pulmonary Hypoplasia Program.

Conditions

• Congenital Diaphragmatic Hernia
• Pulmonary Hypoplasia

Interventions

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

Timeline

• Start date: 2025-04-07
• Primary completion: 2030-04-01
• Completion: 2032-04-01
• First posted: 2025-03-19
• Last updated: 2025-07-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study