Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Georffrey Colby (ucla)

Description

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.

Keywords

Supratentorial Hemorrhage Cerebral Hemorrhage Hemorrhage Aurora Surgiscope System AURORA

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 12 hours of the last known well time or, in patients with wake-up onset, within 12 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

You CAN'T join if...

  • 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

Locations

  • UCLA Ronald Regan Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • University of Washington - Harborside not yet accepting patients
    Seattle Washington 98104 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Integra LifeSciences Corporation
ID
NCT04494295
Study Type
Observational
Last Updated