FETO for Diaphragmatic Hernia
(FETO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial involves placing a small balloon in the unborn baby's windpipe to help their lungs grow. It targets pregnant women whose babies have a severe condition affecting their diaphragm. The balloon helps the baby's lungs develop by blocking the windpipe.
Do I have to stop taking my current medications for the FETO trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
How is the FETO treatment for diaphragmatic hernia different from other treatments?
FETO (Fetoscopic Endoluminal Tracheal Occlusion) is unique because it involves temporarily blocking the fetal trachea with a balloon to promote lung growth, which is not done in other treatments for congenital diaphragmatic hernia. This approach is designed to improve lung development before birth, potentially increasing survival rates, but it can lead to complications like preterm delivery.12345
What data supports the effectiveness of the treatment FETO with Goldballoon Detachable Balloon (GOLDBAL2) for Diaphragmatic Hernia?
Who Is on the Research Team?
Aimen Shaaban, MD
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Are You a Good Fit for This Trial?
This trial is for pregnant women over 18 with a single pregnancy and severe congenital diaphragmatic hernia in the fetus, showing specific lung underdevelopment. Participants must be willing to follow study procedures, live near the Chicago Institute for Fetal Health, and have no major health issues or conditions that could affect safety or compliance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
FETO Procedure
Insertion of the Goldballoon Detachable Balloon into the fetal trachea between 27 weeks 0 days and 29 weeks 6 days of gestation
Balloon Monitoring
Weekly monitoring of fetal lung growth and health status while the balloon is in place
Balloon Removal
Removal of the fetal tracheal balloon ideally at 34 weeks gestation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including infant health status until two years of age
What Are the Treatments Tested in This Trial?
Interventions
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aimen F. Shaaban, MD
Lead Sponsor