Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH) (FETO)
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|ClinicalTrials.gov Identifier: NCT04052828|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : April 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Diaphragmatic Hernia||Device: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fetal Endoscopic Tracheal Occlusion Trial for Congenital Diaphragmatic Hernia (CDH)|
|Actual Study Start Date :||April 5, 2021|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||April 2024|
Experimental: FETO with GOLDBAL2
A balloon will be placed in the airway of the fetus during the FETO procedure.
Device: 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.
- 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 ]Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
- Number of successful retrievals of the GOLDBAL2 [ Time Frame: Removal prior to delivery approximately 34 weeks of gestation ]This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.
- 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 ]Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.
- Change in fetal lung growth [ Time Frame: baseline (before balloon placement), immediately prior to balloon retrieval ]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.
- Gestational age at delivery [ Time Frame: At the time of delivery (up to approximately 34 weeks) ]
- Survival of infant to hospital discharge or 180 days after hospitalized [ Time Frame: Discharge from hospital or up to 180 days in the hospital ]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.
- Number of maternal complications [ Time Frame: up to 4-6 weeks postpartum ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052828
|Contact: Erin Perrone, MDemail@example.com|
|Contact: Marjorie C Treadwell, MDfirstname.lastname@example.org|
|Principal Investigator:||Erin Perrone, MD||University of Michigan|