Intracranial HemorrhagesNCT04983953
Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
An observational study of Intracranial Hemorrhages, run by Heuron Inc. at 1 site in South Korea.
Trial summary
cHS is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain CT images, and clinical decision support system for diagnosing intracranial haemorrhage 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
- Intracranial Hemorrhages
- What is being tested?
- cHS
- Type of treatment
- Medical device
- How many people
- 236 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2021to 28 Jul 2021
- 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 CT images acquired (3) who confirmed with intracranial haemorrhage(abnormal cohort) or not intracranial haemorrhage or normal(normal cohort)
Who may be able to join
- Adults over 19 years old
- Brain CT acquired
- Abnormal cohort: A patient diagnosed with intracranial haemorrhage after a brain CT scan
- Normal cohort: A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan
Who cannot join
- Patients with brain tumor or cerebral toxoplasmosis
- Patients with brain abscess or brain calcification
- Poor or incomplete brain CT image 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 and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
cHS is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain CT images, and clinical decision support system for diagnosing intracranial haemorrhage by automatically analyzing brain CT images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of cHS for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.
- Conditions
- Intracranial Hemorrhages
- Being tested
- cHS
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cHSDevice
Clinical decision support system for diagnosing intracranial haemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Abnormal | A patient diagnosed with intracranial haemorrhage after a brain CT scan Receives: Device: cHS | |
| Normal | A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan Receives: Device: cHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of cHS
Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards
Measured: Within 4 weeks after collecting data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start23 Jun 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983953
- Sponsor's protocol ID
- HR-cHS-01
- Status last verified
- Jan 2022
- First submitted
- 29 Jul 2021
- Last updated
- 14 Jan 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
- ClinicalTrials.gov ID
- NCT04983953
- Acronym / sponsor ID
- HR-cHS-01
- Conditions
- Intracranial Hemorrhages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Heuron Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 30 Jul 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.
cHS is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain CT images, and clinical decision support system for diagnosing intracranial haemorrhage by automatically analyzing brain CT images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of cHS for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abnormal | – | Device: cHSA patient diagnosed with intracranial haemorrhage after a brain CT scan |
| Normal | – | Device: cHSA normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan |
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 CT images acquired (3) who confirmed with intracranial haemorrhage(abnormal cohort) or not intracranial haemorrhage or normal(normal cohort)
Key inclusion criteria (4 listed)
- Adults over 19 years old
- Brain CT acquired
- Abnormal cohort: A patient diagnosed with intracranial haemorrhage after a brain CT scan
- Normal cohort: A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan
Key exclusion criteria (3 listed)
- Patients with brain tumor or cerebral toxoplasmosis
- Patients with brain abscess or brain calcification
- Poor or incomplete brain CT image 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 |
|---|---|---|
| cHSClinical decision support system for diagnosing intracranial haemorrhage | Device | Abnormal, Normal |
Primary outcome
Sensitivity and specificity of cHS
Time frame: Within 4 weeks after collecting data
Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards
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 14 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intracranial Hemorrhages, 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 3 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 14 Jan 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 cHS (time frame: Within 4 weeks after collecting data). 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 14 Jan 2022.