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Recruiting Observational

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

NCT04494295 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2020-10-23
Last updated
2026-02-06

Condition(s) studied

Supratentorial Hemorrhage

Investigational drug(s) / intervention(s)

Aurora Surgiscope System

Aurora Surgiscope System: MIS evacuation of hematoma using the Aurora Surgiscope System

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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Rate of Surgical Success — During surgical procedure to evacuate supratentorial intracerebral hemorrhage
    Rate of surgical success defined as reduction to \< 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan

Trial sites (20)

FacilityCityRegionStatus
Providence Health Burbank California Recruiting
University of Miami Miami Florida Recruiting
University of South Florida Tampa Florida Recruiting
Rush University Medical Center Chicago Illinois Recruiting
MedStar Health Research Institute Baltimore Maryland Not Yet Recruiting
Corewell Health Grand Rapids Michigan Terminated
University of Missouri Columbia Missouri Recruiting
Washington University in St. Louis St Louis Missouri Recruiting
JFK university Edison New Jersey Recruiting
University at Buffalo Buffalo New York Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
University of North Carolina Chapel Hill North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
University of Oklahoma Oklahoma City Oklahoma Recruiting
Pennsylvania State University Hershey Pennsylvania Recruiting
University of Pennsylvania Philadelphia Pennsylvania Terminated
Prisma Health - Upstate Greenville South Carolina Recruiting
UT Health Houston Texas Not Yet Recruiting
University of Utah Salt Lake City Utah Recruiting
University of Washington - Harborview Seattle Washington Recruiting

More Integra LifeSciences Corporation trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04494295 on ClinicalTrials.gov ↗ ← All trials in the USA