Status:
WITHDRAWN
Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
University of Pittsburgh Medical Center
Conditions:
Intracerebral Hematoma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Non-traumatic intracerebral hemorrhage (ICH) affects approximately 100,000 Americans yearly. Up to 30-50% of ICH is fatal, and those patients who survive are often left with significant neurologic dys...
Detailed Description
The introduction of the ROSA stereotactic robot offers an image guided stereotactic approach with greater precision and accuracy than traditional frame-based and frameless methods. While the ROSA has ...
Eligibility Criteria
Inclusion
- Age 18-85
- Head CT demonstrates an acute, spontaneous, supratentorial, primary ICH
- ICH volume ≥30 cc
- Surgery initiated within 48 hours of hospital admission
Exclusion
- Pregnancy at the time of surgery
- Underlying vascular lesion defined as causative source of ICH
- Irreversible coagulopathy
- Profound neurological deficit defined as fixed/dilated pupils, bilateral extensor motor posturing
- Infratentorial or brainstem ICH
- Known life expectancy \<6 months
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03414307
Start Date
September 30 2020
End Date
September 30 2020
Last Update
July 23 2021
Active Locations (1)
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1
UPMC Stroke Institute
Pittsburgh, Pennsylvania, United States, 15213