Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorRodrigo Ruano
About this trial
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton pregnancy
Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks.
Isolated Left CDH with liver up
Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery.
Disqualifiers
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
Trial design
Design model
Single group
Treatments tested in this trial
BALT GoldbBAL2 Detachable Balloon
DeviceLatex balloon, with radio-opaque inclusion
Catheter System
Device100 cm tapered micro-catheter
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: FETO GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of successfully completed FETO procedures
The number of successful placement and removal of balloon during FETO procedure
Time frame
Up to 34 weeks gestation2
Operative time
FETO placement and release operative times reported in minutes
Time frame
Up to 34 weeks gestation3
Frequency of unplanned balloon removal
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Time frame
Up to 34 weeks gestation4
Number of incidences of maternal complications
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Time frame
Up to 41 weeks gestationSecondary outcomes
1
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Volume as measured via ultrasound
Time frame
Up to 41 weeks gestation2
Fetal Lung Growth as measured via LHR
Lung area to head circumference Ratio (LHR) as measured via ultrasound
Time frame
Up to 41 weeks gestation3
Fetal survival
Fetal survival reported in days
Time frame
Up to 24 months post partum4
Number of newborns reported at each oxygen dependency grading
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Time frame
Up to 24 months post partumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rodrigo Ruano
Lead sponsor
University of Miami
Sponsor institution
Source ClinicalTrials.gov