The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
NCT ID: NCT04494295
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2020-10-23
2029-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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AURORA
Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma
Aurora Surgiscope System
MIS evacuation of hematoma using the Aurora Surgiscope System
Interventions
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Aurora Surgiscope System
MIS evacuation of hematoma using the Aurora Surgiscope System
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Oculus Imaging LLC
UNKNOWN
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Sigmund Kulessa
Role: STUDY_DIRECTOR
Integra LifeSciences Corporation
Christopher Kellner, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Providence Health
Burbank, California, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
MedStar Health Research Institute
Baltimore, Maryland, United States
Corewell Health
Grand Rapids, Michigan, United States
University of Missouri
Columbia, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
JFK university
Edison, New Jersey, United States
University at Buffalo
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
UT Health
Houston, Texas, United States
University of Washington - Harborview
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Cynthia Yashinki
Role: primary
Surekha Patel, MBBS
Role: primary
Patricia Orozco
Role: primary
Olivia Christman
Role: primary
Other Identifiers
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C-MIRROR-001
Identifier Type: -
Identifier Source: org_study_id
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