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SYNCHRONISE: LVO Triage Timing and Outcome Study

NCT04608617 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-09-19

No results posted yet for this study

Summary

The objective of this study is to evaluate the impact of Viz LVO in hospital systems with non-interventional and interventional (spoke and hub) stroke centers on the timing and outcomes of patients with suspected acute ischemic stroke indicated for mechanical thrombectomy.

Conditions

  • Stroke, Ischemic

Interventions

DEVICE

Viz LVO (De Novo Number DEN170073)

Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application.

OTHER

Baseline Effectiveness Cohort

No Intervention was performed for the pre-Viz group. Record review to establish operational metrics only occurred.

Sponsors & Collaborators

  • Viz.ai, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Thomas Devlin · CHI Memorial

  • Dr. Ameer Hassan · Valley Baptist

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2023-02-22
Completion
2023-04-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04608617 on ClinicalTrials.gov