Intracerebral HemorrhageNCT04733638
ADVANCE- Automated Detection and Volumetric Assessment of ICH
An observational study of Intracerebral Hemorrhage, run by Viz.ai, Inc. at 5 sites in United States.
Trial summary
To evaluate the performance of the Viz ICH VOLUME algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Viz ICH VOLUME
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Jan 2021to 28 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected acute stroke or intracranial hemorrhage
Who may be able to join
- 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
Who cannot join
- Subjects with poor or incomplete brain imaging.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Presbyterian Medical Center
Charlotte, North Carolina, 28204
Swedish Medical Center Healthone
Englewood, Colorado, 80113
Prisma Health Upstate
Greenville, South Carolina, 29605
Mount Sinai Hospital (Neurosurgery)
New York, New York, 10029
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Automated Detection and Volumetric Assessment of Intracerebral Hemorrhage Using Artificial Intelligence- Multicenter Study
To evaluate the performance of the Viz ICH VOLUME algorithm.
Read the detailed description
To evaluate the performance of the Viz ICH VOLUME algorithm to:
- detect the presence of ICH on brain imaging,
- measure the volume of ICH on brain imaging,
- and to assess the algorithm processing time,
- and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Viz ICH VOLUME
- Keywords
- Artificial Intelligence, ICH
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viz ICH VOLUMEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Viz ICH VOLUME | Patient data collected prior to Viz ICH VOLUME implementation, utilized as a control data set | |
| Post-Viz ICH VOLUME | Patient data collected post-Viz ICH VOLUME implementation Receives: Device: Viz ICH VOLUME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm Performance
Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.
Measured: Up to 10 minutes
Secondary outcomes (6)
Algorithm Processing Time
Total run time in minutes for the algorithm to process the CT scan following receipt
Measured: Up to 10 minutes
Time to Notification
Time in minutes from CT imaging to time an interventionalist was notified
Measured: Up to 10 minutes
Time to Treatment
Time in minutes from CT imaging to start time of treatment
Measured: up to 1 day (1440 minutes)
Length of Stay
Number of days in hospital
Measured: Hospital admit to discharge, up to 30 days
In Hospital Complications
Occurrence of stroke-related or stroke treatment-related complications while in hospital
Measured: Hospital admit to discharge, up to 30 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start26 Jan 2021
- Primary completion15 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viz.ai, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moleen Madziva, Study director, Director of Clinical Affairs at Viz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733638
- Sponsor's protocol ID
- Viz-ICH-02
- Status last verified
- Sep 2024
- First submitted
- 27 Jan 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Detection and Volumetric Assessment of Intracerebral Hemorrhage Using Artificial Intelligence- Multicenter Study
- ClinicalTrials.gov ID
- NCT04733638
- Acronym / sponsor ID
- Viz-ICH-02
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Artificial Intelligence, ICH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Viz.ai, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the performance of the Viz ICH VOLUME algorithm.
Detailed description
To evaluate the performance of the Viz ICH VOLUME algorithm to:
- detect the presence of ICH on brain imaging,
- measure the volume of ICH on brain imaging,
- and to assess the algorithm processing time,
- and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Viz ICH VOLUME | – | –Patient data collected prior to Viz ICH VOLUME implementation, utilized as a control data set |
| Post-Viz ICH VOLUME | – | Device: Viz ICH VOLUMEPatient data collected post-Viz ICH VOLUME implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected acute stroke or intracranial hemorrhage
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects with poor or incomplete brain imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viz ICH VOLUMEViz 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. | Device | Post-Viz ICH VOLUME |
Primary outcome
Algorithm Performance
Time frame: Up to 10 minutes
Sensitivity and specificity of Viz ICH VOLUME in detecting ICH compared to standard of care evaluation.
6 secondary outcomes
Algorithm Processing Time
Time frame: Up to 10 minutes
Time to Notification
Time frame: Up to 10 minutes
Time to Treatment
Time frame: up to 1 day (1440 minutes)
Length of Stay
Time frame: Hospital admit to discharge, up to 30 days
In Hospital Complications
Time frame: Hospital admit to discharge, up to 30 days
Modified Rankin Scale (mRS) at Discharge and 90 Days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moleen Madziva study director
Director of Clinical Affairs at Viz
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by Viz.ai, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm Performance (time frame: Up to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.