Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
(FETO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a procedure where a small balloon is placed in an unborn baby's windpipe to help their lungs grow better. It targets babies with a serious condition called severe congenital diaphragmatic hernia (CDH). The balloon helps by blocking the windpipe, which makes the lungs expand and develop more before birth.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the FETO Goldballoon treatment different from other treatments for congenital diaphragmatic hernia?
What data supports the effectiveness of the treatment Fetal Endoscopic Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia?
Research indicates that FETO, which involves temporarily blocking the trachea (windpipe) of a fetus, can increase survival rates and reduce complications in babies with severe congenital diaphragmatic hernia (a birth defect affecting the diaphragm). The procedure has been shown to promote lung growth and improve outcomes compared to similar cases without the treatment.12678
Who Is on the Research Team?
Yair Blumenfeld
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18-50 with a single fetus diagnosed with severe congenital diaphragmatic hernia (CDH). They must stay near LPCH Stanford, plan to deliver there, and have normal genetic testing results. Excluded are those with latex allergies, certain CDH measurements, placental abnormalities, maternal infections like HIV or Hepatitis B/C, high risk of preterm labor/delivery, significant obesity (BMI >40), or involvement in another study affecting outcomes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Fetal Endoscopic Tracheal Occlusion (FETO) is performed in-utero and the balloon is removed prior to delivery
Follow-up
Children will have follow-up visits until the age of 2 to monitor safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Balt Goldballoon
Balt Goldballoon is already approved in European Union, United States for the following indications:
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Who Is Running the Clinical Trial?
Yair Blumenfeld
Lead Sponsor