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CNV_2020_01 Middle Meningeal Artery EMbolization for the Treatment of SuBduRal HemAtomas with TRUFIL n-BCA

NCT04816591

Middle Meningeal Artery EMbolization for the Treatment of SuBduRal HemAtomas with TRUFIL n-BCA

Associated Conditions

Hemorrhage, Subdural Hematoma

Principal Investigator

Frank Hellinger

Sponsor

Cerenovus

The purpose of this study is to see if TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System is safe and works for the treatment of cSDH. This device has been approved for use in the United States for treatment of another condition in the brain (abnormal connection of blood vessels) which is different from your condition. For this study, TRUFILL n-BCA is an 'investigational device' which means that it has not been approved by the United States Food and Drug Administration for the treatment of cSDH. Data collected in this study will be used to show whether TRUFILL n-BCA is safe and effective for cSDH and will be used to ask for approval from FDA.

This study is currently enrolling.