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FETO Trial for Severe Congenital Diaphragmatic Hernia (CDH)

This study is looking at a procedure called Fetal Endoscopic Tracheal Occlusion (FETO) for pregnant women carrying a baby with severe congenital diaphragmatic hernia (CDH). CDH is a condition where a baby's diaphragm (the muscle that separates the chest and belly) doesn't form completely, allowing organs to move into the chest and prevent the lungs from growing properly. The FETO procedure involves placing a device called the GOLDBAL2 balloon into the baby's windpipe while still in the womb. This study wants to see if it's possible and safe to successfully place and then remove this balloon. You may be able to join if you are pregnant, at least 18 years old, and carrying one baby with severe CDH. The study is currently unclear about its recruitment status.

Study design
This is a small, single-site study that will involve 10 participants. It is a single-arm study, meaning all participants will receive the same intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track the successful placement of the balloon up to 30 weeks of pregnancy and successful retrieval of the balloon up to 35 weeks of pregnancy.

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

NCT05354505

Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Recruiting
NAAges 18+InterventionalTreatment
Vincent Duron
~10 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Placement of the GOLDBAL2 balloon

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total number of subjects with successful placement of the balloon
Measured over Up to 30 weeks
+1 more outcome measured

Conditions

Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Vincent Duron, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Amanda Alonso, MHA
[email protected]
212-342-0261
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 NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) and ability to maintain follow up appointments. NYP/CUIMC will work with the study participant to assist in securing housing 30 minutes from the hospital if this is a challenge to her.
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 NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC)
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 NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) 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. 5. Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen 6. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome 7. Maternal contraindications to elective fetoscopic surgery 8. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery 9. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.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 10. No safe or feasible fetoscopic approach to balloon placement 11. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality 12. Participation in another intervention study that influences maternal and fetal morbidity and mortality.

What this trial measures

  • Total number of subjects with successful placement of the balloonUp to 30 weeks

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

  • Total number of subjects with successful retrieval of the balloonUp to 35 weeks

    Success will be defined by retrieval prior to delivery, including safe retrieval during an ex-utero intrapartum therapy (EXIT) procedure.