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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06216457
Other study ID # SMART-LVO Registry
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date October 31, 2024

Study information

Verified date May 2024
Source Methinks Software SL
Contact Carlotta Calvi
Phone +34639041147
Email research@methinks.ai
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 study sites utilizing existing AI imaging stroke platforms. The main question[s] it aims to answer is: • Performance of and outcomes associated with the use of the Methinks AI stroke imaging medical device in real-world clinical practice.


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 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.


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Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Methinks Software SL Santiago Ortega- global PI

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the sensitivity and specificity of the following Methinks AI modules: Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.
Methinks NCCT algorithm detecting ICHs.
Methinks CTA algorithm detecting ICA, M1, and M2 occlusions.
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).
Secondary Time Potential time reduction - difference in speed to LVO notification between Methinks NCCT-LVO and competitor CTA-LVO. 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).
Secondary Time for NCCT-LVO Notification. 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).
Secondary User experience. Site Principal Investigator will complete questionnaire based upon experience with use of the Methinks software and application. 1 day (Questionnaire completed at individual site enrollment completion.)
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