← Back to all trials
Completed
NCT04816591
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Conditions: Chronic Subdural Hematoma
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 376
Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Location: University of Alabama at Birmingham Birmingham Alabama
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).
Eligibility Criteria
Inclusion Criteria:
* Pre-randomization mRS \/= 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
Source: ClinicalTrials.gov (NCT04816591). StuddyBuddy aggregates publicly available trial information.
