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Device

Tracheal Occlusion for Congenital Diaphragmatic Hernia (CHOP_FETO Trial)

N/A
Recruiting
Led By Holly L Hedrick, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fetal: Normal Karyotype or chromosomal microarray with non-pathologic variants
Pregnant women age 18 years and older, who are able to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights

CHOP_FETO Trial Summary

This trial is testing a new way to treat CDH before birth.

Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe left Congenital Diaphragmatic Hernia (CDH), where the liver has moved up. The baby must have an O/E LHR less than 25%, indicating serious lung underdevelopment, and be no more than 29 weeks + 5 days into gestation.Check my eligibility
What is being tested?
The study tests a procedure using GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter to temporarily block the trachea of fetuses in utero. This may help lungs grow by keeping fluid within them, potentially improving survival rates after birth for babies with severe CDH.See study design
What are the potential side effects?
Possible side effects include risks associated with fetoscopic surgery such as preterm labor, injury to the mother or fetus, infection risk, or complications from anesthesia. Specific side effects related to the balloon device are not detailed but could involve reactions at the insertion site.

CHOP_FETO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My unborn baby's genetic tests are normal.
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I am a pregnant woman, 18 or older, and can give consent.
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My condition involves a left-sided diaphragmatic hernia with liver displacement.
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My unborn baby has severe lung underdevelopment with an O/E LHR below 25%.

CHOP_FETO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful balloon placement and removal.

CHOP_FETO Trial Design

1Treatment groups
Experimental Treatment
Group I: FETO in CDHExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,034 Total Patients Enrolled
Holly L Hedrick, MD5.03 ReviewsPrincipal Investigator - Children's Hospital of Philadelphia and the Center for Fetal Diagnosis and Treatment
Children's Hospital of Philadelphia

Media Library

GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02549820 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: FETO in CDH
Congenital Diaphragmatic Hernia Clinical Trial 2023: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter Highlights & Side Effects. Trial Name: NCT02549820 — N/A
GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02549820 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Seminars in Fetal and Neonatal MedicineJournal
Controversies in the Management of Severe Congenital Diaphragmatic Hernia
Danzer, Enrico, and Holly L. Hedrick. 2014. “Controversies in the Management of Severe Congenital Diaphragmatic Hernia”. Seminars in Fetal and Neonatal Medicine. Elsevier BV. doi:10.1016/j.siny.2014.10.001.
Ultrasound in Obstetrics and GynecologyJournal
Severe Diaphragmatic Hernia Treated by Fetal Endoscopic Tracheal Occlusion
Jani, J. C., K. H. Nicolaides, E. Gratacós, C. M. Valencia, E. Doné, J.-M. Martinez, L. Gucciardo, R. Cruz, and J. A. Deprest. 2009. “Severe Diaphragmatic Hernia Treated by Fetal Endoscopic Tracheal Occlusion”. Ultrasound in Obstetrics and Gynecology. Wiley. doi:10.1002/uog.6450.
Clinics in PerinatologyJournal
Changing Perspectives on the Perinatal Management of Isolated Congenital Diaphragmatic Hernia in Europe
Deprest, Jan A., Eduardo Gratacos, Kypros Nicolaides, Elise Done, Tim Van Mieghem, Leonardo Gucciardo, Filip Claus, et al.. 2009. “Changing Perspectives on the Perinatal Management of Isolated Congenital Diaphragmatic Hernia in Europe”. Clinics in Perinatology. Elsevier BV. doi:10.1016/j.clp.2009.03.004.
Journal of Pediatric SurgeryJournal
Technical Aspects of Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
Deprest, Jan, Kypros Nicolaides, Elisa Done', Paul Lewi, Gerard Barki, Eric Largen, Philip DeKoninck, et al.. 2011. “Technical Aspects of Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2010.10.008.
All > Hernia
~4 spots leftby Dec 2025
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