Supratentorial Hemorrhage
Conditions
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.
Interventions
DEVICEAurora Surgiscope System
MIS evacuation of hematoma using the Aurora Surgiscope System
Sponsors
Integra LifeSciences Corporation
Icahn School of Medicine at Mount Sinai
Oculus Imaging LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Surgical Success | 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 |
Countries
United States
Contacts
CONTACTHabib Nacer-Chérif
STUDY_DIRECTORSigmund Kulessa
Integra LifeSciences Corporation
PRINCIPAL_INVESTIGATORChristopher Kellner, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed