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

Dr Erin Perrone

Status

Enrolling

Conditions

Congenital Diaphragmatic Hernia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04052828

HUM00159792

Details and patient eligibility

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.

Enrollment

10 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed and dated consent
Stated willingness to comply with all study procedures and availability for the duration 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 cardiac defects
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
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 Von Voigtlander Women's Hospital 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 Von Voigtlander Women's Hospital
- Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work.

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 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
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.