Fetoscopic Endoluminal Tracheal Occlusion
ConditionCongenital Diaphragmatic Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Colorado, Denver
About this trial
The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women age 18 years and older, who are able to consent
Singleton pregnancy
Normal Karyotype
Fetal Diagnosis of Isolated Left or Right CDH with liver up
Disqualifiers
Pregnant women <18 years of age.
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Technical limitations precluding fetoscopic surgery
Rubber latex allergy
Trial design
Design model
Single group
Treatments tested in this trial
Fetoscopic Endoluminal Tracheal Occlusion (FETO)
DeviceThis study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E \< 25%; O/E LHR \< 30 %) and right CDH (O/E LHR \< 45%).
Treatment groups
10 Participants
are divided into 3 treatment groupsGroup A: Fetuses with Left CDH (O/E LHR < 25%)Experimental treatment 1 intervention
Group B: Fetuses with L- sided CDH with O/E LHR <30%.Experimental treatment 1 intervention
Group C: Fetuses with R- sided CDH with O/E LHR < 45%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful placement of Balt Goldbal2 balloon
The feasibility of performing the procedure and managing the pregnancy during the period of tracheal occlusion
Time frame
7 weeks after placement2
Successful removal of Balt Goldbal2 balloon
The feasibility of the removal of the device prior to delivery
Time frame
Within 5 weeks prior to delivery3
Gestational age at delivery
Time frame
At delivery4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Maternal complications: preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis)
Time frame
After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)Secondary outcomes
1
Survival at Discharge or at 6 months if still hospitalized
Time frame
Discharge up to 180 days post delivery2
Lung Volume Measurement
Time frame
7 weeks after placement of balloon3
Lung Head Ratio Measurement
Time frame
7 weeks after placement of balloonSponsors and contacts
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Source ClinicalTrials.gov