Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

Completed · Not applicable

Conditions studied: Chronic Subdural Hematoma

In brief

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).

Key facts

Study ID

NCT04816591

Run by

Cerenovus, Part of DePuy Synthes Products, Inc.

People needed

376

Starts

2021-05-27

Expected to finish

2025-03-26

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-randomization mRS </= 3
• Confirmed diagnosis of chronic subdural hematoma
• Completed informed consent

You may not qualify 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

Where it is running

• 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 D.C., 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
• Piedmont Hospital — Atlanta, Georgia, United States
• Wellstar Health System — Marietta, Georgia, United States
• Memorial Health University Health Center — Savannah, Georgia, United States
• University of Maryland — Baltimore, Maryland, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mount Sinai Hospital — New York, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Ohio Health — Columbus, Ohio, United States
• Mercy Health St Vincent Medical Center — Toledo, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital of Research — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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