Supratentorial Hemorrhage Clinical Trial
— MIRROROfficial title:
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | October 15, 2029 |
| Est. primary completion date | October 15, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University at Buffalo | Buffalo | New York |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University of Missouri | Columbia | Missouri |
| United States | Corewell Health | Grand Rapids | Michigan |
| United States | Prisma Health - Upstate | Greenville | South Carolina |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | University of Oklahoma | Oklahoma City | Oklahoma |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Washington University in St. Louis | Saint Louis | Missouri |
| United States | University of Washington - Harborview | Seattle | Washington |
| United States | University of South Florida | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Integra LifeSciences Corporation | Icahn School of Medicine at Mount Sinai, Oculus Imaging LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of Surgical Success | Rate of surgical success defined as reduction to < 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan | During surgical procedure to evacuate supratentorial intracerebral hemorrhage |