RecruitingNot ApplicableNCT06347796

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study


Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

520 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Conventional Surgery and a medical device called Middle Meningeal Artery Embolization (MMAE) for people with chronic subdural hematoma. The study is currently recruiting participants at 31 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREConventional Surgery

Conventional surgery is surgical drainage through burr holes or craniotomy.

DEVICEMiddle 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

View Full Details on ClinicalTrials.gov

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NCT06347796


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