ADVANCE- Automated Detection and Volumetric Assessment of ICH

Viz.ai

Status: Completed

Conditions: Intracerebral Hemorrhage

Treatments: Device: Viz ICH VOLUME

Study type: Observational

Funder types: Industry

Identifiers

NCT04733638

Viz-ICH-02

Details and patient eligibility

About

To evaluate the performance of the Viz ICH VOLUME algorithm.

Full description

To evaluate the performance of the Viz ICH VOLUME algorithm to:

1. detect the presence of ICH on brain imaging,
2. measure the volume of ICH on brain imaging,
3. and to assess the algorithm processing time,
4. and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18 and older)
• Presenting with symptoms suspicious for an acute stroke / intracranial hemorrhage
• Having a complete imaging data set including NCCT +/- MRI, CTA and/or MRA

Exclusion criteria

• Subjects with poor or incomplete brain imaging.

Trial design

1,000 participants in 2 patient groups

Pre-Viz ICH VOLUME

Description:

Patient data collected prior to Viz ICH VOLUME implementation, utilized as a control data set

Post-Viz ICH VOLUME

Description:

Patient data collected post-Viz ICH VOLUME implementation

Treatment:

Device: Viz ICH VOLUME