Aurora Surgiscope System
DeviceMIS evacuation of hematoma using the Aurora Surgiscope System
Recruiting
NCT Number: NCT04494295
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Providence Health, Burbank, California, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Rate of Surgical Success
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Integra LifeSciences Corporation
Industry
Collaborators
- Icahn School of Medicine at Mount Sinai
- Oculus Imaging LLC
Registry information
Acronym: MIRROR
Important dates
- Study start
- 2020
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Jul 31, 2020
- Registry last updated
- Feb 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.