Back to Trials
NCT04494295Recruiting

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Integra LifeSciences Corporation

Start Date

10/23/2020

Completion Date

10/15/2029

Summary

This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Subject Age is \> 18 * Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume \> 20 mL, assessed via standard of care techniques * Subject Surgery can be initiated within 24 hours of the last known well time or, in patients with wake-up onset, within 24 hours of the time the patient awoke with symptoms. * Subject has a NIHSS score \> 5 * Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2 * Subject with a CT Angiography demonstrating no vascular malformation Exclusion Criteria: * Subject has an underlying vascular lesion defined as causative source of ICH * Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing * Subject has an Infratentorial or brainstem ICH * Subject has a known life expectancy \< 6 months * Subject has an uncorrectable coagulopathy * Subject has a mechanical heart valve * Subject is pregnant * Subject participates in another concurrent interventional clinical trial * Subject who is unable to meet study follow-up requirements

Interventions

DEVICE

Aurora Surgiscope System

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Supratentorial Hemorrhage

Locations

Providence Health

Burbank, California 91505

United States

University of Miami

Miami, Florida 33136

United States

University of South Florida

Tampa, Florida 33606

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

MedStar Health Research Institute

Baltimore, Maryland 21237

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

University of Missouri

Columbia, Missouri 65201

United States

Washington University in St. Louis

St Louis, Missouri 63110

United States

JFK university

Edison, New Jersey 08820

United States

University at Buffalo

Buffalo, New York 14260

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

University of North Carolina

Chapel Hill, North Carolina 27599-1350

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

University of Oklahoma

Oklahoma City, Oklahoma 73104

United States

Pennsylvania State University

Hershey, Pennsylvania 17033

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Prisma Health - Upstate

Greenville, South Carolina 29601

United States

UT Health

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84112

United States

University of Washington - Harborview

Seattle, Washington 98104

United States