Actively Recruiting
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
Led by Dr Erin Perrone · Updated on 2025-06-22
10
Participants Needed
1
Research Sites
373 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 Michigan Medicine. 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 Michigan Medicine. This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital 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 (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated consent
- Willingness to comply with all study procedures and be available for the study duration
- Singleton pregnancy
- No pathogenic variants on microarray or pathologic findings on karyotype
- Fetal echocardiogram showing expected changes from CDH with no major cardiac defects
- Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as observed-to-expected lung to head ratios (LHR) less than 25% with liver up
- Gestational age at FETO procedure between 27 weeks 0 days and 29 weeks 6 days if LHR <25%
- Meets psychosocial criteria including living within 30 minutes of Von Voigtlander Women's Hospital
- Has a support person available to stay during pregnancy near the hospital
- Willing to comply with restrictions such as no exercise, sexual intercourse, or work for the remainder of pregnancy
You will not qualify if you...
- 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
- Bilateral CDH, unilateral CDH with LHR > 25%, or unilateral CDH with LHR <25% but liver completely down in abdomen
- Additional fetal or genetic abnormalities impacting care or outcome
- Maternal contraindications to elective fetoscopic surgery
- Significant placental abnormalities known at enrollment or surgery
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
- Maternal HIV, Hepatitis B with positive surface antigen, or Hepatitis C with virus in blood
- No safe or feasible fetoscopic approach for balloon placement
- Social instability or inability to comply with study protocol as evaluated by social work
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
E
Erin Perrone, MD
CONTACT
C
Caitlin Clifford, MD
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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