Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
NCT ID: NCT04816591
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
376 participants
INTERVENTIONAL
2021-05-27
2025-03-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental: Interventional Cohort: Treatment Arm
Standard of Care Surgery + Embolization
Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Standard of Care Surgery + Embolization
Standard of Care Surgery Only
Standard of Care Surgery Only
Standard of Care Surgery
Standard of Care Surgery Only
Interventional Cohort: Treatment Arm
Standard of Care Medical Management + Embolization
Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
Standard of Care Medical Management + Embolization
Standard of Care Medical Management Only
Standard of Care medical management only.
Standard of Care Medical Management
Standard of Care Medical Management Only
Interventions
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Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Standard of Care Surgery + Embolization
Standard of Care Surgery
Standard of Care Surgery Only
Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
Standard of Care Medical Management + Embolization
Standard of Care Medical Management
Standard of Care Medical Management Only
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of chronic subdural hematoma
* Completed informed consent
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Cerenovus, Part of DePuy Synthes Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Kellner, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Ansaar Rai, MD
Role: PRINCIPAL_INVESTIGATOR
West Virginia University
Locations
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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
Semmes Murphey Foundation
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Stroke Institute
Plano, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
West Virginia Hospital
Morgantown, West Virginia, United States
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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Other Identifiers
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CNV_2020_01
Identifier Type: -
Identifier Source: org_study_id