Clinical trial NCT04494295: The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Official title: The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Supratentorial Hemorrhage
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Oculus Imaging LLC
First posted: 2020-07-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general population with an acute, spontaneous, primary, supratentorial ICH

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 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: 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

Primary outcomes:
measure: Rate of Surgical Success
timeFrame: During surgical procedure to evacuate supratentorial intracerebral hemorrhage
Secondary outcomes:
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Health
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Houston
country: United States
facility: UT Health
state: Texas
city: Seattle
country: United States
facility: University of Washington - Harborview
state: Washington
Study officials:
affiliation: Integra LifeSciences Corporation
name: Sigmund Kulessa
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Christopher Kellner, MD
role: PRINCIPAL_INVESTIGATOR
References: