Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a prospective, multi-center, open-label, randomized controlled study in which
subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization
for the treatment of chronic subdural hematomas (cSDH).
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Endovascular
Enrollment Eligibility
Inclusion Criteria:
- Pre-randomization mRS - Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
Exclusion Criteria:
- 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