RECRUITING

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

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Conditions

Congenital Diaphragmatic Herniapregnantfetal endoscopic tracheal occlusion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-05
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04052828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed and dated consent
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Singleton pregnancy
  4. * No pathogenic variants on microarray or pathologic findings on karyotype
  5. * Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
  6. * Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as observed-to-expected (o/e) lung to head ratios (LHR) \<25% with liver up
  7. * 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
  8. * Meets psychosocial criteria
  9. * Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
  10. * 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 Von Voigtlander Women's Hospital
  11. * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work.
  1. * Multi-fetal pregnancy
  2. * History of latex allergy
  3. * History of preterm labor or incompetent cervix (requiring cerclage), short cervix (≤20mm), or uterine anomaly predisposing to preterm labor
  4. * Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
  5. * Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
  6. * Maternal contraindications to elective fetoscopic surgery
  7. * Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
  8. * Maternal isoimmunization or neonatal alloimmune thrombocytopenia
  9. * 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. * 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.

Contacts and Locations

Study Contact

Erin Perrone, MD
CONTACT
734-936-8464
eperrone@med.umich.edu
Marjorie C Treadwell, MD
CONTACT
734-764-1406
mtread@med.umich.edu

Principal Investigator

Erin Perrone, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: Dr Erin Perrone

  • Erin Perrone, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-05
Study Completion Date2028-06

Study Record Updates

Study Start Date2021-04-05
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • pregnant
  • fetal endoscopic tracheal occlusion

Additional Relevant MeSH Terms

  • Congenital Diaphragmatic Hernia