Active, Not Recruiting

NCT Number: NCT02549820

Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Congenital Diaphragmatic Hernia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pulmonary Hypoplasia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant women age 18 years and older, who are able to consent
Singleton pregnancy

Fetal:

Normal Karyotype or chromosomal microarray with non-pathologic variants
Diagnosis of Isolated Left CDH with liver up
Gestation at enrollment prior to 29 weeks plus 5 days
SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) < 25%

Exclusion criteria

Pregnant women < 18 years
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Technical limitations precluding fetoscopic surgery
Rubber latex allergy
Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
Psychosocial ineligibility, precluding consent
Fetal Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Treatment and study plan

GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Device

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

Primary outcomes

Successful balloon placement and removal.

Time frame: 7 weeks

Successful balloon placement and removal will be counted per patient. FETO insertion will be attempted up to 3 times in a single pregnant woman/ fetus.

The maximum duration of balloon implantation, if placed at 27 weeks 0 days and removed in the 34th week, is 7 weeks. For those balloons placed later in gestation or removed earlier electively or emergently, the duration will be shorter.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Acronym: CHOP_FETO

Important dates

Study start: 2015
Primary completion: 2025
Study completion: 2027
First posted: Sep 15, 2015
Registry last updated: Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting