The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
ConditionSupratentorial Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIntegra LifeSciences Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
general population with an acute, spontaneous, primary, supratentorial ICH
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Aurora Surgiscope System
DeviceMIS evacuation of hematoma using the Aurora Surgiscope System
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: AURORA1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
During surgical procedure to evacuate supratentorial intracerebral hemorrhageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Integra LifeSciences Corporation
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborator
Oculus Imaging LLC
Collaborator
Source ClinicalTrials.gov