Ischemic StrokeNCT05572619
Evaluation of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images
An observational study of Ischemic Stroke, run by Heuron Inc. at 1 site in South Korea.
Trial summary
cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- 1st Reading and 2nd Reading
- Type of treatment
- Medical device
- How many people
- 479 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2022to 8 Sep 2022
- How long will I take part?
- 14 Weeks
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) Adults over 19 years old (2) Brain non-contrast CT, CT perfusion and CT angiography acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)
Who may be able to join
- Adults over 19 years old
- Brain non-contrast CT, CT perfusion and CT angiography acquired
- Positive group: A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
- Negative group: A normal person or a patient not diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
Who cannot join
- Poor or incomplete brain non-contrast CT, CT perfusion and CT angiography quality
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
About this study
Official title: An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images
cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used.
- Conditions
- Ischemic Stroke
- Being tested
- 1st Reading, 2nd Reading
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1st ReadingDevice
Also called Stage 1
The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion.
2nd ReadingDevice
Also called Stage 2
The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Positive group | A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography Receives: Device: 1st Reading; Device: 2nd Reading | |
| Negative group | A normal person or a patient not diagnosed with intracranial haemorrhage after a non-contrast CT, CT perfusion and CT angiography Receives: Device: 1st Reading; Device: 2nd Reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of medical team compared with/without cELVO
Sensitivity and specificity of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO
Measured: Within 2 weeks after completion of reading
Secondary outcomes (5)
Accuracy of medical team compared with/without cELVO
Accuracy of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO
Measured: Within 2 weeks after completion of reading
ROC Curve for medical team compared with/without cELVO
ROC Curve of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO
Measured: Within 2 weeks after completion of reading
AUC values for medical team compared with/without cELVO
AUC values of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO
Measured: Within 2 weeks after completion of reading
Sensitivity and specificity of each reader compared with/without cELVO
Sensitivity and specificity of determining large vessel occlusion of each reader when using cELVO compared to not using cELVO
Measured: Within 2 weeks after completion of reading
Sensitivity and specificity of cELVO
Sensitivity and specificity of cELVO in diagnosis of large vessel occlusion based on golden standards
Measured: Within 2 weeks after completion of reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start22 Mar 2022
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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 crossover
- Time perspective
- Other
- Enrolment
- 479 participants (actual)
- Target duration
- 14 Weeks
Sponsor and investigators
- Lead sponsor
- Heuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myeong Jin Kim, M.D.pH.D, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572619
- Sponsor's protocol ID
- HR-cELVO-01
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images
- ClinicalTrials.gov ID
- NCT05572619
- Acronym / sponsor ID
- HR-cELVO-01
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Heuron Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 7 Oct 2022 (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.
cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images, and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used.
Study design
- Observational model
- Case crossover
- Time perspective
- Other
- Target follow-up
- 14 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive group | – | Device: 1st Reading, Device: 2nd ReadingA patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography |
| Negative group | – | Device: 1st Reading, Device: 2nd ReadingA normal person or a patient not diagnosed with intracranial haemorrhage after a non-contrast CT, CT perfusion and CT angiography |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) Adults over 19 years old (2) Brain non-contrast CT, CT perfusion and CT angiography acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)
Key inclusion criteria (4 listed)
- Adults over 19 years old
- Brain non-contrast CT, CT perfusion and CT angiography acquired
- Positive group: A patient diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
- Negative group: A normal person or a patient not diagnosed with large vessel occlusion after a non-contrast CT, CT perfusion and CT angiography
Key exclusion criteria (1 listed)
- Poor or incomplete brain non-contrast CT, CT perfusion and CT angiography quality
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 |
|---|---|---|
| 1st ReadingAlso: Stage 1The medical team visually checks the non-contrast CT without cELVO and diagnose the large vessel occlusion. | Device | Negative group, Positive group |
| 2nd ReadingAlso: Stage 2The medical team visually checks the non-contrast CT with assistance from the cELVO and diagnose the large vessel occlusion. | Device | Negative group, Positive group |
Primary outcome
Sensitivity and specificity of medical team compared with/without cELVO
Time frame: Within 2 weeks after completion of reading
Sensitivity and specificity of determining large vessel occlusion of medical team when using cELVO compared to not using cELVO
5 secondary outcomes
Accuracy of medical team compared with/without cELVO
Time frame: Within 2 weeks after completion of reading
ROC Curve for medical team compared with/without cELVO
Time frame: Within 2 weeks after completion of reading
AUC values for medical team compared with/without cELVO
Time frame: Within 2 weeks after completion of reading
Sensitivity and specificity of each reader compared with/without cELVO
Time frame: Within 2 weeks after completion of reading
Sensitivity and specificity of cELVO
Time frame: Within 2 weeks after completion of reading
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 7 Oct 2022.
- 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.
Myeong Jin Kim, M.D.pH.D principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Heuron Inc. at 1 site in South Korea.
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 4 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Sensitivity and specificity of medical team compared with/without cELVO (time frame: Within 2 weeks after completion of reading). 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 7 Oct 2022.