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Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
Sponsor: The University of Texas Medical Branch, Galveston
Summary
The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: * Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.
Key Details
Gender
All
Age Range
40 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
520
Start Date
2024-11-01
Completion Date
2029-02
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Conventional Surgery
Conventional surgery is surgical drainage through burr holes or craniotomy.
Middle Meningeal Artery Embolization (MMAE)
Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device.
Locations (31)
Mayo Clinic Arizona
Phoenix, Arizona, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Missouri Healthcare
Columbia, Missouri, United States
Washington University, St. Louis
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
JFK Neuroscience Institute, JFK University Medical Center
Edison, New Jersey, United States
Rutgers, The State University of New Jersey
Newark, New Jersey, United States
Ichan School of Medicine at Mount Sinai
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States
University of Pennyslvania
Philadelphia, Pennsylvania, United States
Philadelphia Neurological Institute
Upland, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas Health Science Center-Houston
Houston, Texas, United States
University of Texas Health Science Center-San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States