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
Qualifiers
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
Treatments tested in this trial
- BALT GoldbBAL2 Detachable Balloon
- Catheter System
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Rodrigo Ruano
Lead sponsor
University of Miami
Sponsor institution
Source ClinicalTrials.gov