Status:
NOT_YET_RECRUITING
Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans
Lead Sponsor:
Methinks Software SL
Collaborating Sponsors:
Santiago Ortega- global PI
Conditions:
Stroke, Ischemic
Stroke Hemorrhagic
Eligibility:
All Genders
22+ years
Brief Summary
The goal of this prospective observational study is to assess the effectiveness and performance of Methinks AI stroke imaging software platform in acute Code Stroke patients, and as a comparator to st...
Detailed Description
This is a prospective observational medical device clinical trial that aims to assess the diagnostic performance of Methinks Investigational Device on detecting LVO and ICH on plain NCCT and CTA, in c...
Eligibility Criteria
Inclusion
- Subjects with acute neurological symptoms suggestive of Stroke, ischemic or hemorrhagic ("Code Stroke"), regardless of presence or absence of final Stroke diagnosis.
- Subjects aged 22 years or older.
- NCCT performed for Code Stroke screening.
- If the patient does not have a hemorrhage, a CTA (head and neck, performed for Code Stroke screening) should also be performed.
- NCCT and CTA have been processed by Methinks AI software.
Exclusion
- ● Subject imaging does not meet Image Acquisition and DICOM Tag Requirements
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06216457
Start Date
July 1 2024
End Date
October 31 2024
Last Update
May 29 2024
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