Phase
Condition
Hemorrhage
Brain Injury
Stroke
Treatment
Aurora Surgiscope System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, inpatients with wake-up onset, within 24 hours of the time the patient awoke withsymptoms.
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
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 orbilateral 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
Study Design
Connect with a study center
Providence Health
Burbank, California 91505
United StatesSite Not Available
UCLA Ronald Regan Medical Center
Los Angeles, California 90095
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Corewell Health
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Spectrum Health
Grand Rapids, Michigan 49503
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65201
United StatesActive - Recruiting
Washington University in St. Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Cooper Health System
Camden, New Jersey 08103
United StatesSite Not Available
University at Buffalo
Buffalo, New York 14260
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
University of Oklahoma
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesTerminated
Prisma Health - Upstate
Greenville, South Carolina 29601
United StatesActive - Recruiting
UT Health
Houston, Texas 77030
United StatesSite Not Available
University of Washington - Harborview
Seattle, Washington 98104
United StatesActive - Recruiting
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