- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04052828
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH) (FETO)
Fetal Endoscopic Tracheal Occlusion Trial for Congenital Diaphragmatic Hernia (CDH)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erin Perrone, MD
- Phone Number: 734-936-8464
- Email: eperrone@med.umich.edu
Study Contact Backup
- Name: Marjorie C Treadwell, MD
- Phone Number: 734-764-1406
- Email: mtread@med.umich.edu
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
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Contact:
- Erin Perrone, MD
- Phone Number: 734-936-8464
- Email: eperrone@med.umich.edu
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Contact:
- Marjorie C Treadwell, MD
- Phone Number: 734-764-1406
- Email: mtread@med.umich.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FETO with GOLDBAL2
A balloon will be placed in the airway of the fetus during the FETO procedure.
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This will take place between gestation of 27w0d - 29w6d.
The balloon will be removed at approximately 34 weeks gestation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of successful retrievals of the GOLDBAL2
Time Frame: Removal prior to delivery approximately 34 weeks of gestation
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This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.
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Removal prior to delivery approximately 34 weeks of gestation
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Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.
Time Frame: 27w0d - 29w6d
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Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
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27w0d - 29w6d
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)
Time Frame: baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval
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Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.
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baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval
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Change in fetal lung growth
Time Frame: baseline (before balloon placement), immediately prior to balloon retrieval
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Fetal ultrasounds will be done weekly while the balloon is in place.
Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR immediately prior to balloon removal.
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baseline (before balloon placement), immediately prior to balloon retrieval
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Gestational age at delivery
Time Frame: At the time of delivery (up to approximately 34 weeks)
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At the time of delivery (up to approximately 34 weeks)
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Survival of infant to hospital discharge or 180 days after hospitalized
Time Frame: Discharge from hospital or up to 180 days in the hospital
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This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point.
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Discharge from hospital or up to 180 days in the hospital
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Number of maternal complications
Time Frame: up to 4-6 weeks postpartum
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Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection.
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up to 4-6 weeks postpartum
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin Perrone, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00159792
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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