Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
ConditionCongenital Diaphragmatic Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, Davis
About this trial
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 UC Davis Medical Center. 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 UC Davis Medical Center.
This study requires that study participants live within 30 minutes of the UC Davis Medical Center 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
Disqualifiers
Adults unable to consent
Prisoners
Multi-fetal pregnancy
History of latex allergy
Trial design
Design model
Single group
Treatments tested in this trial
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
DeviceThis will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: FETO with GOLDBAL2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Time frame
27 weeks 0 days to 29 weeks 6 days2
Number of successful retrievals of the GOLDBAL2
This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.
Time frame
Removal prior to delivery approximately 34 weeks of gestationSecondary outcomes
1
Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)
Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.
Time frame
baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval2
Change in fetal lung growth
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.
Time frame
baseline (before balloon placement), immediately prior to balloon retrieval3
Gestational age at delivery
Time frame
At the time of delivery (up to approximately 34 weeks)4
Survival of infant to hospital discharge or 180 days after hospitalized
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.
Time frame
Discharge from hospital or up to 180 days in the hospitalSponsors and contacts
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Source ClinicalTrials.gov