The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Last updated: February 17, 2025
Sponsor: Integra LifeSciences Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Brain Injury

Stroke

Treatment

Aurora Surgiscope System

Clinical Study ID

NCT04494295
C-MIRROR-001
  • Ages > 18
  • All Genders

Study 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

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

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Aurora Surgiscope System
Phase:
Study Start date:
October 23, 2020
Estimated Completion Date:
October 15, 2029

Connect with a study center

  • Providence Health

    Burbank, California 91505
    United States

    Site Not Available

  • UCLA Ronald Regan Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Cooper Health System

    Camden, New Jersey 08103
    United States

    Site Not Available

  • University at Buffalo

    Buffalo, New York 14260
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Terminated

  • Prisma Health - Upstate

    Greenville, South Carolina 29601
    United States

    Active - Recruiting

  • UT Health

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Washington - Harborview

    Seattle, Washington 98104
    United States

    Active - Recruiting

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