The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Integra LifeSciences

Status

Enrolling

Conditions

Supratentorial Hemorrhage

Treatments

Device: Aurora Surgiscope System

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04494295

C-MIRROR-001

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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