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
More Details
- Status
- Recruiting
- Sponsor
- Integra LifeSciences Corporation