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NCT Number: NCT05421676

Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at UC Davis Medical Center. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at UC Davis Medical Center.

This study requires that study participants live within 30 minutes of the UC Davis Medical Center in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.

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Key information

Conditions

Congenital Diaphragmatic Hernia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Amy Powne, MSN, RN

CONTACT

[email protected]

916-717-4690

Shinjiro Hirose, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
  • Pregnant women, age 18 years and older
  • Singleton pregnancy
  • No pathogenic variants on microarray or pathologic findings on karyotype
  • Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
  • Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25% with liver up
  • Gestational age at FETO procedure: if o/e LHR <25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
  • Meets psychosocial criteria
  • 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 criteria

  • Adults unable to consent
  • Prisoners
  • Multi-fetal pregnancy
  • History of latex allergy
  • History of preterm labor or incompetent cervix (requiring cerclage), short cervix (<20mm), or uterine anomaly predisposing to preterm labor
  • Psychosocial ineligibility
  • 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.
  • Bilateral CDH, unilateral CDH with o/e LHR > 25% or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
  • Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
  • Maternal contraindications to elective fetoscopic surgery
  • Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
  • Maternal isoimmunization or neonatal alloimmune thrombocytopenia
  • 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
  • No safe or feasible fetoscopic approach to balloon placement

Treatment and study plan

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)

Device

This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.

Primary outcomes

  1. 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.

    Time frame: 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.

  2. Number of successful retrievals of the GOLDBAL2

    Time frame: Removal 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.

Secondary outcomes

  1. Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)

    Time frame: baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval

    Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.

  2. Change in fetal lung growth

    Time frame: baseline (before balloon placement), immediately prior to balloon retrieval

    Fetal ultrasounds will be done weekly while the balloon is in place. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR immediately prior to balloon removal.

  3. Gestational age at delivery

    Time frame: At the time of delivery (up to approximately 34 weeks)

  4. Survival of infant to hospital discharge or 180 days after hospitalized

    Time frame: Discharge from hospital or up to 180 days in the hospital

    This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point.

  5. Number of maternal complications

    Time frame: up to 4-6 weeks postpartum

    Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Powne, MSN, RN

CONTACT

[email protected]

916-717-4690

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Acronym: FETO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2022
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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