A Diagnostic Test on DeepDoc-an AI-based Decision Support System

DeepDoc - Clinical Validation of an AI-based Decision Support System in the Early Diagnostic Evaluation of Neurological Diseases: a Prospective Multi-center Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04055766

Enrollment

4000

Registered

2019-08-14

Start date

2020-09-01

Completion date

2021-03-01

Last updated

2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Meningitis/Encephalitis, Stroke, Vertigo

Keywords

Artificial Intelligence

Brief 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 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.

Interventions

DEVICEDeepDoc AI-based Decision Support System

Patients are diagnosed by the DeepDoc within 24 hours of admission.

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache. 2. Neurological examination results and imaging changes within 24 hours of admission.

Exclusion criteria

Patients discharged, transferred to the hospital, or died within 24 hours after admission.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of diagnosis by DeepDoc AI-based Decision Support System	24 hours	Accuracy of diagnosis by DeepDoc and compare this result with doctors

Secondary

Measure	Time frame	Description
Sensitivity of diagnosis by DeepDoc AI-based Decision Support System	24 hours	Sensitivity of diagnosis by DeepDoc and compare this result with doctors
Specificity of diagnosis by DeepDoc AI-based Decision Support System	24 hours	Specificity of diagnosis by DeepDoc and compare this result with doctors

Contacts

Primary ContactZhao Gang

zhaogang@fmmu.edu.cn02984775368

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026