Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

NCT02549820 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 15-011714
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia

Keywords

Congenital Diaphragmatic Hernia; Tracheal Occlusion

Outcome Measures

Primary Outcomes (1)

• Successful balloon placement and removal.

  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.

  7 weeks

Study Arms (1)

FETO in CDH

EXPERIMENTAL

Fetoscopic Endoluminal Tracheal Occlusion (FETO) will be performed by placing a detachable balloon inside the fetal airway and removing the balloon after several weeks. Devices: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Device: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter

Interventions

GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter DEVICE

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

FETO in CDH

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.

  PMID: 19658113 BACKGROUND

• Deprest J, Nicolaides K, Done' E, Lewi P, Barki G, Largen E, DeKoninck P, Sandaite I, Ville Y, Benachi A, Jani J, Amat-Roldan I, Gratacos E. Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. J Pediatr Surg. 2011 Jan;46(1):22-32. doi: 10.1016/j.jpedsurg.2010.10.008.

  PMID: 21238635 BACKGROUND

• Deprest JA, Gratacos E, Nicolaides K, Done E, Van Mieghem T, Gucciardo L, Claus F, Debeer A, Allegaert K, Reiss I, Tibboel D. Changing perspectives on the perinatal management of isolated congenital diaphragmatic hernia in Europe. Clin Perinatol. 2009 Jun;36(2):329-47, ix. doi: 10.1016/j.clp.2009.03.004.

  PMID: 19559323 BACKGROUND

• Danzer E, Hedrick HL. Controversies in the management of severe congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2014 Dec;19(6):376-84. doi: 10.1016/j.siny.2014.10.001. Epub 2014 Nov 7.

  PMID: 25454678 BACKGROUND

• Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11.

  PMID: 25447987 BACKGROUND

Related Links

• FETO at The Children's Hospital of Philadelphia
• CHOP Center for Fetal Diagnosis and Treatment
• CHOP Pulmonary Hypoplasia Program

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Holly L Hedrick, MD

  Children's Hospital of Philadelphia and the Center for Fetal Diagnosis and Treatment

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Surgery

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: September 15, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)