NCT05572619

Evaluation of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images

An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 479 (actual)
• Sponsor: Heuron Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team. The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	1st Reading	The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.
DEVICE	2nd Reading	The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.

Timeline

• Start date: 2022-03-22
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2022-10-07
• Last updated: 2022-10-07

Locations

1 site across 1 country: South Korea