NCT02549820

Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Summary All patients will complete a standard prenatal evaluation at the Center for Fetal Diagnosis and Treatment (CFDT) to find out if they are candidates. 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, 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 25 women will be enrolled in the FETO study. The mother and her unborn baby will undergo two procedures. A balloon will be placed in the unborn baby's 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. Mothers enrolled in this study must remain near the fetal center, under close supervision, from the time of balloon placement through delivery in the 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. Infants will be followed at CHOP at 6 months, 12 months, and 2 years of age and then long-term in the Pulmonary Hypoplasia Program at The Children's Hospital of Philadelphia.

Conditions

• Congenital Diaphragmatic Hernia
• Pulmonary Hypoplasia

Interventions

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

Timeline

• Start date: 2015-07-01
• Primary completion: 2025-05-01
• Completion: 2027-07-01
• First posted: 2015-09-15
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study