Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia
Mauro H. Schenone
Summary
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Singleton pregnancy * Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks * Isolated severe left CDH with O/E LHR \< 25% ) * Gestation age at enrollment prior to 29 wks plus 6 days. * Pulmonary hypoplasia with ultrasound O/E LHR \< 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery. * Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound * Patient meets psychosocial criteria: abl…
Interventions
- DeviceBALT GOLDBALL 2 detachable latex ballon
Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
- DeviceBALTACCIBDPE100 Microcatheter
Used to deliver the detachable balloon
- DeviceStorz fetoscopic operating sheath and miniature telescope/fetoscope
Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.
Location
- Mayo Clinic MinnesotaRochester, Minnesota