ADVANCE- Automated Detection and Volumetric Assessment of ICH

Intracerebral Hemorrhage Clinical Trial

Official title:

Automated Detection and Volumetric Assessment of Intracerebral Hemorrhage Using Artificial Intelligence- Multicenter Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04733638
• Other study ID #: Viz-ICH-02
• Status: Enrolling by invitation
• Start date: January 26, 2021
• Est. completion date: February 2023

Study information

• Verified date: April 2022
• Source: Viz.ai, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the performance of the Viz ICH VOLUME algorithm.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: February 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Device:
• Viz ICH VOLUME
Viz ICH VOLUME software is a module that identifies and segments Intraparenchymal Hemorrhage (IPH) from NCCT imaging. This software is for investigational use in the study and is not FDA cleared. For subjects who undergo a brain scan, Viz will use deep learning algorithms to analyze computed tomography (CT) or magnetic resonance (MR) images of the brain for ICH in parallel to standard of care image interpretation. If a suspected ICH is detected, Viz will perform an automatic volumetric analysis and will send a notification to a specialist, such as a neurointerventionalist or a neurosurgeon. Notifications prompt the specialist to review the patient's case. Additionally, non-diagnostic previewing of DICOM images, and HIPAA-compliant text messaging and phone calls are available in the software platform. Viz ICH VOLUME is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man.

Locations

Country	Name	City	State
United States	Presbyterian Medical Center	Charlotte	North Carolina
United States	Swedish Medical Center Healthone	Englewood	Colorado
United States	Prisma Health Upstate	Greenville	South Carolina
United States	Mount Sinai Hospital (Neurosurgery)	New York	New York
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Viz.ai, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algorithm Performance	Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.	Up to 10 minutes
Secondary	Algorithm Processing Time	Total run time in minutes for the algorithm to process the CT scan following receipt	Up to 10 minutes
Secondary	Time to Notification	Time in minutes from CT imaging to time an interventionalist was notified	Up to 10 minutes
Secondary	Time to Treatment	Time in minutes from CT imaging to start time of treatment	up to 1 day (1440 minutes)
Secondary	Length of Stay	Number of days in hospital	Hospital admit to discharge, up to 30 days
Secondary	In Hospital Complications	Occurrence of stroke-related or stroke treatment-related complications while in hospital	Hospital admit to discharge, up to 30 days
Secondary	Modified Rankin Scale (mRS) at Discharge and 90 Days	The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. A score of 0 is a patient with no residual symptoms. Scores increase with severity to 5 which equals severe disability.	90 days