A Phase II Trial of Fetal Embolization for Vein of Galen Malformation

Recruiting N/A Interventional Study
Vein of Galen Malformations
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Darren Orbach · Other
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About This Trial
This is a prospective, single-arm non-randomized interventional study of fetuses to assess the efficacy and safety of fetal embolization of VOGM. Subjects will receive a one-time study intervention of fetal embolization, at or after 34 weeks of gestation. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to h…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at the narrowest point of the sinus along the rostral-cauda…
Contacts

Darren Orbach, MD PhD

617-355-5012

Darren.Orbach@childrens.harvard.edu

CONTACT