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FETO for Severe Congenital Diaphragmatic Hernia (CDH)

This study is testing a treatment called Fetal Endoscopic Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon (GOLDBAL2) for babies with severe congenital diaphragmatic hernia (CDH) while they are still in the womb. This treatment aims to help the baby's lungs develop better. You might be able to join if you are pregnant with a single baby, are 18 or older, and meet other specific health criteria. The study will involve placing the GOLDBAL2 balloon between 27 and 29 weeks of pregnancy, and then removing it around 34 weeks. The main goals are to see how successfully the balloon can be placed and removed. This is a small, early-stage study at UC Davis Medical Center, and it is currently unclear if it is actively recruiting.

Study design
This is a small, single-site study (pilot trial) involving 10 pregnant women. It is designed to evaluate the feasibility and safety of the intervention.
What's involved
You would have the Goldballoon Detachable Balloon placed between 27 and 29 weeks of pregnancy, and it would be removed around 34 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures successful balloon placement between 27 and 29 weeks, and successful removal around 34 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05421676

Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

Recruiting
NAAges 18+InterventionalTreatment
University of California, Davis
~10 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.
Measured over 27 weeks 0 days to 29 weeks 6 days
+1 more outcome measured

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
California1

Who to contact

Amy Powne, MSN, RN
[email protected]
916-717-4690
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willing to reside within 30 minutes of UC Davis Medical Center and ability to maintain follow up appointments
Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near the UC Davis Medical Center.
Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

Exclusion

Inability to reside within 30 minutes of UC Davis Medical Center or inability to maintain follow up appointments
Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate. 7. Bilateral CDH, unilateral CDH with o/e LHR \> 25% or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen 8. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome 9. Maternal contraindications to elective fetoscopic surgery 10. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery 11. Maternal isoimmunization or neonatal alloimmune thrombocytopenia 12. Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure 13. No safe or feasible fetoscopic approach to balloon placement

What this trial measures

  • Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.27 weeks 0 days to 29 weeks 6 days

    Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.

  • Number of successful retrievals of the GOLDBAL2Removal prior to delivery approximately 34 weeks of gestation

    This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.