Status:
COMPLETED
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Lead Sponsor:
Cerenovus, Part of DePuy Synthes Products, Inc.
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 c...
Detailed Description
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 emboliz...
Eligibility Criteria
Inclusion
- Pre-randomization mRS \</= 3
- Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2025
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT04816591
Start Date
May 27 2021
End Date
March 26 2025
Last Update
December 8 2025
Active Locations (33)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Carondelet St Joseph's Hospital
Tucson, Arizona, United States, 85710
3
John Muir Physician Network Clinical Research Center
Walnut Creek, California, United States, 94598
4
Swedish Medical Center
Englewood, Colorado, United States, 80113