Actively Recruiting
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia
Led by University of California, Davis · Updated on 2025-12-15
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of treating severe Congenital Diaphragmatic Hernia (CDH) in unborn babies using a procedure called Fetal Endoscopic Tracheal Occlusion (FETO) with a Goldballoon Detachable Balloon (GOLDBAL2) and a Delivery Microcatheter. This pilot trial is conducted at a single center and focuses on pregnant women whose fetuses have severe lung underdevelopment due to CDH. The study aims to understand how well the balloon placement and removal work within specific gestational ages and to assess related health outcomes for mother and baby. The treatment involves placing a balloon in the fetal airway between 27 weeks 0 days and 29 weeks 6 days of pregnancy. The balloon is ideally removed between 34 weeks 0 days and 34 weeks 6 days, with timing decided by the fetal treatment team. Participants must live close to the study center to attend weekly follow-ups while the balloon is in place and until delivery. The procedure restricts normal daily activities such as exercise, sexual intercourse, and working during the remainder of the pregnancy. A support person must be available to stay with the participant. During the trial, researchers will monitor the success of balloon placement and removal, changes in fetal lung size through MRI scans, gestational age at delivery, survival of the infant up to hospital discharge or 180 days, and any maternal complications up to 4 to 6 weeks after birth. Weekly visits and close follow-up will help track these outcomes. The total study duration includes the pregnancy period from balloon placement through delivery and postpartum monitoring.
CONDITIONS
Brief Title
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to comply with all study procedures and psychosocial criteria
- Pregnant women aged 18 years or older
- Singleton pregnancy
- No pathogenic variants on genetic testing
- Fetal echocardiogram showing changes expected with CDH and no major cardiac defects
- Severe fetal CDH with observed to expected lung-to-head ratio less than 25% and liver up
- Gestational age between 27 weeks 0 days and 29 weeks 6 days at time of FETO procedure
- Willing to live within 30 minutes of UC Davis Medical Center and attend weekly follow-ups
- Has a support person available to stay during pregnancy
- Able to comply with restrictions on exercise, sexual intercourse, and work for the remainder of pregnancy
You will not qualify if you...
- Unable to provide informed consent
- Prisoners
- Multiple pregnancy (twins or more)
- History of latex allergy
- History of preterm labor, incompetent cervix, short cervix less than 20mm, or uterine anomalies
- Psychosocial ineligibility including inability to stay near study center or maintain appointments
- Bilateral CDH or unilateral CDH with lung-to-head ratio greater than 25% or liver fully down in abdomen
- Additional fetal or genetic abnormalities affecting care
- Maternal contraindications to fetoscopic surgery
- Significant placental problems such as abruption or accreta
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
- Maternal HIV or active Hepatitis B or C infection with risk of fetal transmission
- No safe or feasible approach to perform balloon placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From 27 weeks 0 days to 29 weeks 6 days gestation
Participants undergo the FETO procedure where a balloon is placed in the fetus's airway between 27 weeks 0 days and 29 weeks 6 days of gestation.
1 visit (in-person) for the procedure
Duration - Until approximately 4 to 6 weeks postpartum
Participants have the balloon removed at approximately 34 weeks gestation and attend weekly follow-up visits until delivery and up to 4-6 weeks postpartum to monitor maternal and fetal health.
Weekly visits until delivery and postpartum
Trial Site Locations
Total: 1 location
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
A
Amy Powne, MSN, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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