The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

NCT ID: NCT04494295

Last Updated: 2025-07-28

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-23

Study Completion Date

2029-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Supratentorial Hemorrhage

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AURORA

Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma

Aurora Surgiscope System

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Oculus Imaging LLC

UNKNOWN

Sponsor Role collaborator

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

University of Miami

Miami, Florida, United States

Site Status RECRUITING

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

MedStar Health Research Institute

Baltimore, Maryland, United States

Site Status NOT_YET_RECRUITING

Corewell Health

Grand Rapids, Michigan, United States

Site Status TERMINATED

University of Missouri

Columbia, Missouri, United States

Site Status RECRUITING

Washington University in St. Louis

St Louis, Missouri, United States

Site Status RECRUITING

JFK university

Edison, New Jersey, United States

Site Status NOT_YET_RECRUITING

University at Buffalo

Buffalo, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Pennsylvania State University

Hershey, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status TERMINATED

Prisma Health - Upstate

Greenville, South Carolina, United States

Site Status RECRUITING

UT Health

Houston, Texas, United States

Site Status RECRUITING

University of Washington - Harborview

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Habib Nacer-Chérif

Role: CONTACT

+33626190029

Facility Contacts

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Jeffrey Figueroa

Role: primary

Adriana Saravia

Role: primary

Shardonnai Sims

Role: primary

Rebecca McWilliams

Role: primary

Cynthia Yashinki

Role: primary

Brooke Hoffman

Role: primary

Ramie Heo

Role: primary

Surekha Patel, MBBS

Role: primary

Michaela Laskowski

Role: primary

Emily Svendsen

Role: primary

Patricia Orozco

Role: primary

Joyce Barmen

Role: primary

Michael Omini

Role: primary

Olivia Christman

Role: primary

Rosie Gaddy

Role: primary

Andrea Gaitan

Role: primary

Do Lim

Role: primary

Other Identifiers

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C-MIRROR-001

Identifier Type: -

Identifier Source: org_study_id

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