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

Last updated: March 6, 2025
Sponsor: Dr Erin Perrone
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Pentalogy Of Cantrell

Treatment

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

Clinical Study ID

NCT04052828
HUM00159792
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated consent

  • Stated willingness to comply with all study procedures and availability for theduration of the study

  • Singleton pregnancy

  • No pathogenic variants on microarray or pathologic findings on karyotype

  • Fetal echocardiogram with changes expected with CDH and no major structural cardiacdefects

  • Fetal CDH (left or right) with severe pulmonary hypoplasia, defined asobserved-to-expected (o/e) lung to head ratios (LHR) <25% with liver up

  • Gestational age at FETO procedure: if o/e LHR <25% will be done at 27 weeks plus 0days to 29 weeks plus 6 days

  • Meets psychosocial criteria

  • Willing to reside within 30 minutes of Von Voigtlander Women's Hospital andability to maintain follow up appointments

  • Patient has a support person (e.g. spouse, partner, friend, parent) that isavailable to stay with her for the duration of the pregnancy near VonVoigtlander Women's Hospital

  • Willing to comply with restrictions of daily living including inability toexercise, have intercourse, or return to work.

Exclusion

Exclusion Criteria:

  • 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 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 orbe known to have an impact on outcome

  • Maternal contraindications to elective fetoscopic surgery

  • Significant placental abnormalities (abruption, chorioangioma, accreta) known attime of enrollment and/or surgery

  • Maternal isoimmunization or neonatal alloimmune thrombocytopenia

  • Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presenceof virus in maternal blood due to risk of fetal transmission during the procedure

  • No safe or feasible fetoscopic approach to balloon placement

  • Social work will meet with each patient to evaluate the social situation and supportsystem. Identifiable issues of social instability or compliance with the protocolwill exclude her as a potential candidate.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Phase:
Study Start date:
April 05, 2021
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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