Clinical Trial

Fetal Treatment of Galenic Malformations

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2020-06-13; most recent amendment 2025-12-15.
Status change: Suspended → Active, Not Recruiting 2024-10-09
Status change: Recruiting → Suspended 2024-09-11
Status change: Not Yet Recruiting → Recruiting 2020-08-19
Trial Details
NCT Number NCT04434729
Lead Sponsor Darren Orbach
Conditions Vein of Galen Malformations
Enrollment 7 participants
Start Date 2022-09-30
Primary Completion 2024-09-06 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-01-06