Status:
COMPLETED
A Study to Detect Progression of Mass Effect from Unilateral Brain Lesions
Lead Sponsor:
Mayo Clinic
Conditions:
Non-traumatic Hemispheric Brain Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.
Eligibility Criteria
Inclusion
- Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation.
- Patients admitted the Neuroscience ICU for serial neurological monitoring.
- Patients whose care is not expected to include immediate surgical decompression.
Exclusion
- Patients under the age of 18.
- Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent.
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04745884
Start Date
February 4 2021
End Date
December 2 2024
Last Update
February 19 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905