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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
AURORA Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma
  • Device: Aurora Surgiscope System
    MIS evacuation of hematoma using the Aurora Surgiscope System

Recruiting Locations

University of South Florida
Tampa, Florida 33606
Contact:
Chanel Mercurius
cmercurius@tgh.org

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Rebecca McWilliams
rebecca_mcwilliams@rush.edu

Corewell Health
Grand Rapids, Michigan 49503
Contact:
Allison Werner
allison.werner@corewellhealth.org

University of Missouri
Columbia, Missouri 65201
Contact:
Brooke Hoffman
hoffmanba@health.missouri.edu

Washington University in St. Louis
Saint Louis, Missouri 63110
Contact:
Ramie Heo
heor@wustl.edu

University at Buffalo
Buffalo, New York 14260
Contact:
Michaela Laskowski
mlaskowski@ubns.com

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Emily Svendsen
emily.svendsen@mountsinai.org

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Joyce Barmen
barmenj2@ccf.org

University of Oklahoma
Oklahoma City, Oklahoma 73104
Contact:
Michael Omini
michael-omini@ouhsc.edu

Prisma Health - Upstate
Greenville, South Carolina 29601
Contact:
Rosie Gaddy
rosie.gaddy@prismahealth.org

University of Washington - Harborview
Seattle, Washington 98104
Contact:
Do Lim
dolim@uw.edu

More Details

NCT ID
NCT04494295
Status
Recruiting
Sponsor
Integra LifeSciences Corporation

Study Contact

Crystal George
4699684132
crystal.george@integralife.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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