Intracerebral HemorrhageNCT03865979
AI ENRICH - AI Detection of ICH
A study testing Viz RECRUIT in people with Intracerebral Hemorrhage, run by Viz.ai, Inc. at 6 sites in United States.
Trial summary
To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation. 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 RECRUIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jan 2020to 28 Apr 2023
- Phase
- Interventional
- 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
Who may be able to join
- Subjects with stroke symptoms who undergo CT brain imaging.
Who cannot join
- Subjects with poor or incomplete CT brain imaging.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
SUNY Buffalo
Buffalo, New York, 14203
Cooper University Hospital
Camden, New Jersey, 08103
Geisinger Medical Center
Danville, Pennsylvania, 17822
Northshore University Health System
Evanston, Illinois, 60201
UAMS Medical Center
Little Rock, Arkansas, 72205
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial
To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.
Read the detailed description
This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Viz RECRUIT
- 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 RECRUITDevice
Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | Subject CT images assessed by Viz RECRUIT software in "real time" analysis All subjects in which the Viz RECRUIT software is utilized will be identified per cohort described below per PI confirmation of ENRICH Trial status/Study ID.
Cohort A: Subjects with imaging data Cohort B: Subjects with imaging data and ultimately enrolled as part of the ENRICH Trial Receives: Device: Viz RECRUIT |
| Control Arm | No intervention | Subjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start23 Jan 2020
- Primary completion15 Mar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viz.ai, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nico Corporation
- Responsible party
- Sponsor
- Investigators
- Brian T Jankowitz, MD, Principal investigator, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865979
- Sponsor's protocol ID
- VIZ-ICH-01
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial
- ClinicalTrials.gov ID
- NCT03865979
- Acronym / sponsor ID
- VIZ-ICH-01
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Artificial Intelligence, ICH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Viz.ai, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nico Corporation
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 7 Mar 2019 (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 RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.
Detailed description
This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Device: Viz RECRUITSubject CT images assessed by Viz RECRUIT software in "real time" analysis All subjects in which the Viz RECRUIT software is utilized will be identified per cohort described below per PI confirmation of ENRICH Trial status/Study ID. Cohort A: Subjects with imaging data Cohort B: Subjects with imaging data and ultimately enrolled as part of the ENRICH Trial |
| Control Arm | No intervention | –Subjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with stroke symptoms who undergo CT brain imaging.
Key exclusion criteria (1 listed)
- Subjects with poor or incomplete CT 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 RECRUITViz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB | Device | Intervention Arm |
Primary outcome
Performance
Time frame: Enrollment
Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.
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: No
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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.
Brian T Jankowitz, MD principal investigator
Cooper Norcross Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viz RECRUIT in people with Intracerebral Hemorrhage, run by Viz.ai, Inc. at 6 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 1 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 6 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?
Performance (time frame: Enrollment). 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.