The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
- Conditions
- Supratentorial Hemorrhage
- Interventions
- Device: Aurora Surgiscope System
- Registration Number
- NCT04494295
- Lead Sponsor
- Integra LifeSciences Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AURORA Aurora Surgiscope System Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Providence Health
🇺🇸Burbank, California, United States
University of Miami
🇺🇸Miami, Florida, United States
UT Health
🇺🇸Houston, Texas, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Prisma Health - Upstate
🇺🇸Greenville, South Carolina, United States
University of Washington - Harborview
🇺🇸Seattle, Washington, United States