Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
- Conditions
- Chronic Subdural Hematoma
- Registration Number
- NCT04816591
- Lead Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
- 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 chronic subdural hematomas (cSDH).
- 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 embolization for the treatment of cSDH.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 376
- Pre-randomization mRS </= 3
- Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Effectiveness 180 days post procedure Hematoma recurrence/progression or requiring re-intervention
- Secondary Outcome Measures
Name Time Method Safety: Change in mRS 180 days post procedure Change in mRS
Effectiveness 180 days post procedure Reduction of hematoma volume
Trial Locations
- Locations (33)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Carondelet St Joseph's Hospital
🇺🇸Tucson, Arizona, United States
John Muir Physician Network Clinical Research Center
🇺🇸Walnut Creek, California, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
University of Miami - Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Scroll for more (23 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States