Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cerenovus, Part of DePuy Synthes Products, Inc.
This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pre-randomization mRS \</= 3
Confirmed diagnosis of chronic subdural hematoma
Completed informed consent
You may not be if
Acute subdural hematoma
Prior treatment of target subdural hematoma
Markwalder assessment \>/= 3
Glasgow Coma Scale \< 9
Presumed microbial superinfection
CT or MRI evidence of intracranial tumor or mass lesion
Life expectancy \< 1 year
Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
Current involvement in another clinical trial that may confound study endpoints
Clareo Health | Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
