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COMPLETED
NCT04816591
NA

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

Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

376

Start Date

2021-05-27

Completion Date

2025-03-26

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

DEVICE

Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Standard of Care Surgery + Embolization

OTHER

Standard of Care Surgery

Standard of Care Surgery Only

DEVICE

Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System

Standard of Care Medical Management + Embolization

OTHER

Standard of Care Medical Management

Standard of Care Medical Management Only

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 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