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Fetal Treatment of Galenic Malformations
Sponsor: Darren Orbach
Summary
This is a prospective, single-arm non-randomized interventional study of fetuses to assess the safety and efficacy of fetal embolization of Vein of Galen Malformation (VOGM). Subjects will receive a one-time study intervention of fetal embolization. Follow-up assessments will be collected every 4 weeks until delivery, as per standard of care. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
7
Start Date
2022-09-30
Completion Date
2026-08
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils
The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States