Recruiting

Minimally Invasive HemorrhageThe MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Sponsor:

Integra LifeSciences Corporation

Code:

NCT04494295

Conditions

Supratentorial Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aurora Surgiscope System

Study Details

Brief 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.

Conditions

Supratentorial Hemorrhage

Study ID

NCT04494295

Start date

Oct 23, 2020

Status verified date

Feb, 2026

Completion date

Oct 15, 2029

Anticipated

Primary completion date

Oct 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

AURORA

Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma

Interventions

Aurora Surgiscope System

MIS evacuation of hematoma using the Aurora Surgiscope System

Primary outcome measure

Rate of Surgical Success [ Time Frame: During surgical procedure to evacuate supratentorial intracerebral hemorrhage ]

Central Contacts and Locations

Central contacts

Habib Nacer-Chérif

+33626190029 habib.nacercherif@integralife.com

Locations

Providence Health

Recruiting

Burbank, California, United States, 91505

Contacts

Jeffrey Figueroa

Jeffrey.Figueroa@providence.org

Principal Investigator:

Adi Iyer, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Adriana Saravia

a.saravia@med.miami.edu

Principal Investigator:

Adib Abla, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Shardonnai Sims

shardonnaisims@tgh.org

Principal Investigator:

Kunal Vakharia, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Rebecca McWilliams

rebecca_mcwilliams@rush.edu

Principal Investigator:

R. Webster Crowley, MD

University of Missouri

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Brooke Hoffman

hoffmanba@health.missouri.edu

Principal Investigator:

Michael Chicoine, MD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ramie Heo

heor@wustl.edu

Principal Investigator:

Joshua Osbun, MD

JFK university

Recruiting

Edison, New Jersey, United States, 08820

Principal Investigator:

Brian Jankowitz, MD

University at Buffalo

Recruiting

Buffalo, New York, United States, 14260

Contacts

Michaela Laskowski

mlaskowski@ubns.com

Principal Investigator:

Adnan Siddiqui, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Emily Svendsen

emily.svendsen@mountsinai.org

Principal Investigator:

Tomoyoshi Shigematsu, MD, PhD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599-1350

Principal Investigator:

Edward Yap, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Joyce Barmen

barmenj2@ccf.org

Principal Investigator:

Mark Bain, MD

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Michael Omini

michael-omini@ouhsc.edu

Principal Investigator:

Andrew Bauer, MD

Pennsylvania State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

Ephraim Church, MD

Prisma Health - Upstate

Recruiting

Greenville, South Carolina, United States, 29601

Contacts

Rosie Gaddy

rosie.gaddy@prismahealth.org

Principal Investigator:

Jan Varas Machaj, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Karol Budohoski, MD

University of Washington - Harborview

Recruiting

Seattle, Washington, United States, 98104

Contacts

Do Lim

dolim@uw.edu

Principal Investigator:

Michael Levitt, MD

More Information

Sponsor

Integra LifeSciences Corporation

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Integra LifeSciences Corporation on 2026-02-06.