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

NCT ID: NCT04052828

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2028-06-30

Brief 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.

Conditions

Congenital Diaphragmatic Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FETO with GOLDBAL2

A balloon will be placed in the airway of the fetus during the FETO procedure.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.

Interventions

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

This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dr Erin Perrone

OTHER

Sponsor Role: lead

Responsible Party

Dr Erin Perrone

Associate Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Erin Perrone, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin Perrone, MD

Role: CONTACT

eperrone@med.umich.edu

734-936-8464

Caitlin Clifford, MD

Role: CONTACT

cmcliff@med.umich.edu

734-764-3096

Facility Contacts

Erin Perrone, MD

Role: primary

eperrone@med.umich.edu

734-936-8464

Caitlin Clifford, MD

Role: backup

cmcliff@med.umich.edu

734-764-3096

Other Identifiers

HUM00159792

Identifier Type: -

Identifier Source: org_study_id