An observational study in Stroke, Ischemic, Stroke Hemorrhagic and Stroke, Acute, sponsored by Methinks Software SL. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Methinks Software SL · Observational
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 study sites utilizing existing AI imaging stroke platforms.
The main question[s] it aims to answer is:
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 consecutive acute Code Stroke activations at the emergency department.
Demographic, Clinical and Imaging variables will be collected from stroke onset through Day 7 or Discharge, whichever is earlier. Methinks results will be collected exclusively for research purposes and no clinical decisions will be made based on the output. Diagnostic performance of NCCT-LVO Methinks output will be assessed using DSA and/or CTA as ground truth. Presence of ICH will be assessed using an independent neuroradiologist final reading. The Clinical impact on workflow will be retrospectively estimated based on the reduction of time to decision in both transfer patients and the ones directly arriving to the emergency department (ED)
Informed consent forms (ICF) will be waived, as approved by the IRB.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with Methinks Software SL as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Consecutive Code Stroke patients, aged 22 or older, regardless of presence or absence of ultimate diagnosis of Ischemic Stroke or Hemorrhagic Stroke.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
● Subject imaging does not meet Image Acquisition and DICOM Tag Requirements
Subjects with Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.
Device: AI software for Stroke
Subjects with Methinks NCCT algorithm detecting ICHs.
Device: AI software for Stroke
Subjects with final diagnosis confirmed not to be Stroke (i.e. stroke mimic) or any type of stroke not determined to be: LVO (ICA, M1 or M2) or ICH.
Device: AI software for Stroke
AI Software for Non-Contrast Head CT (Computed Tomography) and CT Angiography, utilized for Code Stroke screening, notification and triage.
Also known as: Methinks AI Software
Evaluate the sensitivity and specificity of the following Methinks AI modules:
1. Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions. 2. Methinks NCCT algorithm detecting ICHs. 3. Methinks CTA algorithm detecting ICA, M1, and M2 occlusions.
Time frame: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
Time Potential time reduction - difference in speed to LVO notification between Methinks NCCT-LVO and competitor CTA-LVO.
Time frame: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
Time for NCCT-LVO Notification.
Time frame: Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
User experience.
Site Principal Investigator will complete questionnaire based upon experience with use of the Methinks software and application.
Time frame: 1 day (Questionnaire completed at individual site enrollment completion.)
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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