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

Cerenovus, Part of DePuy Synthes Products, Inc.376 enrolled

Overview

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).

This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

376

Conditions

Chronic Subdural Hematoma

Interventions

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

Standard of Care Surgery + Embolization

Standard of Care SurgeryOTHER

Standard of Care Surgery Only

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

Standard of Care Medical Management + Embolization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pre-randomization mRS \</= 3 * Confirmed diagnosis of chronic subdural hematoma * Completed informed consent Exclusion Criteria: * 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

Locations (33)

Outcomes

Primary Outcomes

Effectiveness

Hematoma recurrence/progression or requiring re-intervention

Time frame: 180 days post procedure

Occurrence of All Adverse Events (AEs) up to 6 Months

AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated.

Time frame: Up to 6 months

Secondary Outcomes

Effectiveness

Reduction of hematoma volume

Time frame: 180 days post procedure

Safety: Change in mRS

Change in mRS

Time frame: 180 days post procedure

Data from ClinicalTrials.gov

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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

...and 23 more locations