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Overcoming roadblocks in clinical innovation via high fidelity simulation: use of a phantom simulator to achieve FDA and IRB approval of a clinical trial of fetal embolization of vein of Galen malformations

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Published in 2023 at "Journal of NeuroInterventional Surgery"

DOI: 10.1136/jnis-2022-019658

Abstract: Background Vein of Galen malformation (VOGM) is a rare, life-threatening vascular malformation in neonates and is treated with embolization. However, even at the most experienced centers, patients face high mortality and morbidity. In utero treatment… read more here.

Keywords: phantom simulator; vein galen; trial; vogm ... See more keywords