Status:
RECRUITING
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Oculus Imaging LLC
Conditions:
Supratentorial Hemorrhage
Eligibility:
All Genders
18+ years
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 ava...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 15 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04494295
Start Date
October 23 2020
End Date
October 15 2029
Last Update
July 28 2025
Active Locations (19)
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1
Providence Health
Burbank, California, United States, 91505
2
University of Miami
Miami, Florida, United States, 33136
3
University of South Florida
Tampa, Florida, United States, 33606
4
Rush University Medical Center
Chicago, Illinois, United States, 60612