StrokeNCT04055766
A Diagnostic Test on DeepDoc-an AI-based Decision Support System
An observational study of Stroke and Headache, run by Xijing Hospital.
Trial summary
DeepDoc is an AI-based decision support system for the early etiology diagnosis of neurological diseases using clinical data points from patients admitted to hospital within 24 hours.This study aims to evaluate whether the diagnosis of the DeepDoc AI-based decision support system is better than the doctor's initial… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- DeepDoc AI-based Decision Support System
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Mar 2021
- How long will I take part?
- 3 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 4000 consecutive patients suspected of stroke，meningitis/encephalitis, vertigo and headache（1000 cases of each disease) are admitted to the department of neurology that consented to involvement in the study.
Who may be able to join
- Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache.
- Neurological examination results and imaging changes within 24 hours of admission.
Who cannot join
- Patients discharged, transferred to the hospital, or died within 24 hours after admission.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: DeepDoc - Clinical Validation of an AI-based Decision Support System in the Early Diagnostic Evaluation of Neurological Diseases: a Prospective Multi-center Study
DeepDoc is an AI-based decision support system for the early etiology diagnosis of neurological diseases using clinical data points from patients admitted to hospital within 24 hours.This study aims to evaluate whether the diagnosis of the DeepDoc AI-based decision support system is better than the doctor's initial diagnosis by a multi-center, superiority diagnostic study.
Read the detailed description
The doctor completes the admission note within 24 hours after the patient is admitted to the hospital. After informed consent is given to the patient who meet the inclusion criteria, open the DeepDoc to fill in the patient identification information. Then take the picture of the initial diagnosis of the admission note page and upload it to DeepDoc, fill the doctor's initial diagnosis into the DeppDoc. And put the patient's clinical data points into the DeepDoc to get a DeepdDoc diagnosis.
- Conditions
- Stroke, Headache, Vertigo, Meningitis/Encephalitis
- Being tested
- DeepDoc AI-based Decision Support System
- Keywords
- Artificial Intelligence
- Medical subject headings
- Stroke, Headache, Vertigo, Meningitis, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepDoc AI-based Decision Support SystemDevice
Patients are diagnosed by the DeepDoc within 24 hours of admission.
| Study group | Role | What they receive |
|---|---|---|
| Meningitis/Encephalitis | Patients with clinical signs and symptoms suspected of meningitis/encephalitis Receives: Device: DeepDoc AI-based Decision Support System | |
| Stroke | Patients with clinical signs and symptoms suspected of stroke Receives: Device: DeepDoc AI-based Decision Support System | |
| Headache | Patients with clinical signs and symptoms suspected of headache Receives: Device: DeepDoc AI-based Decision Support System | |
| Vertigo | Patients with clinical signs and symptoms suspected of vertigo Receives: Device: DeepDoc AI-based Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of diagnosis by DeepDoc AI-based Decision Support System
Accuracy of diagnosis by DeepDoc and compare this result with doctors
Measured: 24 hours
Secondary outcomes (2)
Sensitivity of diagnosis by DeepDoc AI-based Decision Support System
Sensitivity of diagnosis by DeepDoc and compare this result with doctors
Measured: 24 hours
Specificity of diagnosis by DeepDoc AI-based Decision Support System
Specificity of diagnosis by DeepDoc and compare this result with doctors
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Sep 2020 (estimated)
- Primary completion9 Sep 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao Gang, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055766
- Sponsor's protocol ID
- DeepDoc-M5
- Status last verified
- Jul 2019
- First submitted
- 4 Aug 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeepDoc - Clinical Validation of an AI-based Decision Support System in the Early Diagnostic Evaluation of Neurological Diseases: a Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT04055766
- Acronym / sponsor ID
- DeepDoc-M5
- Conditions
- Stroke, Headache, Vertigo, Meningitis/Encephalitis
- Keywords
- Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 9 Sep 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 14 Aug 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.
DeepDoc is an AI-based decision support system for the early etiology diagnosis of neurological diseases using clinical data points from patients admitted to hospital within 24 hours.This study aims to evaluate whether the diagnosis of the DeepDoc AI-based decision support system is better than the doctor's initial diagnosis by a multi-center, superiority diagnostic study.
Detailed description
The doctor completes the admission note within 24 hours after the patient is admitted to the hospital. After informed consent is given to the patient who meet the inclusion criteria, open the DeepDoc to fill in the patient identification information. Then take the picture of the initial diagnosis of the admission note page and upload it to DeepDoc, fill the doctor's initial diagnosis into the DeppDoc. And put the patient's clinical data points into the DeepDoc to get a DeepdDoc diagnosis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Meningitis/Encephalitis | – | Device: DeepDoc AI-based Decision Support SystemPatients with clinical signs and symptoms suspected of meningitis/encephalitis |
| Stroke | – | Device: DeepDoc AI-based Decision Support SystemPatients with clinical signs and symptoms suspected of stroke |
| Headache | – | Device: DeepDoc AI-based Decision Support SystemPatients with clinical signs and symptoms suspected of headache |
| Vertigo | – | Device: DeepDoc AI-based Decision Support SystemPatients with clinical signs and symptoms suspected of vertigo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 4000 consecutive patients suspected of stroke，meningitis/encephalitis, vertigo and headache（1000 cases of each disease) are admitted to the department of neurology that consented to involvement in the study.
Key inclusion criteria (2 listed)
- Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache.
- Neurological examination results and imaging changes within 24 hours of admission.
Key exclusion criteria (1 listed)
- Patients discharged, transferred to the hospital, or died within 24 hours after admission.
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 |
|---|---|---|
| DeepDoc AI-based Decision Support SystemPatients are diagnosed by the DeepDoc within 24 hours of admission. | Device | Headache, Meningitis/Encephalitis, Stroke, Vertigo |
Primary outcome
Accuracy of diagnosis by DeepDoc AI-based Decision Support System
Time frame: 24 hours
Accuracy of diagnosis by DeepDoc and compare this result with doctors
2 secondary outcomes
Sensitivity of diagnosis by DeepDoc AI-based Decision Support System
Time frame: 24 hours
Specificity of diagnosis by DeepDoc AI-based Decision Support System
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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.
Zhao Gang study director
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Headache, run by Xijing Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Gang (02984775368, zhaogang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of diagnosis by DeepDoc AI-based Decision Support System (time frame: 24 hours). 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 13 Dec 2019; AzTrials last refreshed its copy on 26 Oct 2026.