Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05421676

Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

Led by University of California, Davis · Updated on 2025-12-15

10

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Willingness to follow all study procedures and availability for the study duration
  • Pregnant women aged 18 years or older
  • Singleton pregnancy
  • No disease-causing genetic changes on microarray or karyotype
  • Fetal echocardiogram showing changes expected with CDH and no major heart defects
  • Fetal CDH (left or right) with severe lung underdevelopment, defined as observed/expected lung-to-head ratio less than 25% with liver up
  • Gestational age at FETO procedure between 27 weeks 0 days and 29 weeks 6 days if lung-to-head ratio is less than 25%
  • Willing to live within 30 minutes of UC Davis Medical Center and maintain weekly follow-ups
  • Has a support person (such as spouse, partner, friend, or parent) available to stay during pregnancy near UC Davis Medical Center
  • Willing to follow daily living restrictions including no exercise, no intercourse, and no work during pregnancy
Not Eligible

You will not qualify if you...

  • Adults unable to provide consent
  • Prisoners
  • Pregnancies with more than one fetus
  • History of latex allergy
  • History of preterm labor, incompetent cervix requiring cerclage, short cervix less than 20 mm, or uterine abnormalities causing risk of early labor
  • Psychosocial ineligibility including inability to live near UC Davis Medical Center or maintain follow-ups
  • Social instability or inability to comply with study protocol as judged by social work evaluation
  • Bilateral CDH, or unilateral CDH with lung-to-head ratio greater than 25%, or unilateral CDH with liver completely down in abdomen
  • Additional fetal or genetic problems impacting care or outcomes
  • Maternal contraindications to elective fetoscopic surgery
  • Major placental problems known at enrollment or surgery (e.g., abruption, chorioangioma, accreta)
  • Maternal isoimmunization or neonatal alloimmune thrombocytopenia
  • Maternal HIV, Hepatitis B with positive surface antigen, or Hepatitis C with virus present in blood due to fetal transmission risk
  • No safe or feasible fetoscopic approach to balloon placement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UC Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

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Research Team

A

Amy Powne, MSN, RN

CONTACT

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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Fetal Endoscopic Tracheal Occlusion for CDH (CDH) | DecenTrialz