The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Purpose
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.
Condition
- Supratentorial Hemorrhage
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| AURORA | Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma |
|
Recruiting Locations
Providence Health
Burbank 5331835, California 5332921 91505
Burbank 5331835, California 5332921 91505
University of Miami
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
University of South Florida
Tampa 4174757, Florida 4155751 33606
Tampa 4174757, Florida 4155751 33606
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
University of Missouri
Columbia 4381982, Missouri 4398678 65201
Columbia 4381982, Missouri 4398678 65201
Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
JFK university
Edison 5097529, New Jersey 5101760 08820
Edison 5097529, New Jersey 5101760 08820
Contact:
Surekha Patel, MBBS
Surekha Patel, MBBS
University at Buffalo
Buffalo 5110629, New York 5128638 14260
Buffalo 5110629, New York 5128638 14260
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27599-1350
Chapel Hill 4460162, North Carolina 4482348 27599-1350
Contact:
Patricia Orozco
Patricia Orozco
University of Oklahoma
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
Pennsylvania State University
Hershey 5193342, Pennsylvania 6254927 17033
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Olivia Christman
Olivia Christman
Prisma Health - Upstate
Greenville 4580543, South Carolina 4597040 29601
Greenville 4580543, South Carolina 4597040 29601
University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Salt Lake City 5780993, Utah 5549030 84112
Contact:
Andrew Grandemange, MBA
Andrew Grandemange, MBA
University of Washington - Harborview
Seattle 5809844, Washington 5815135 98104
Seattle 5809844, Washington 5815135 98104
More Details
- NCT ID
- NCT04494295
- Status
- Recruiting
- Sponsor
- Integra LifeSciences Corporation