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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04055766
• Other study ID #: DeepDoc-M5
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2019
• Source: Xijing Hospital
• Contact: Zhao Gang
• Phone: 02984775368
• Email: zhaogang[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 diagnosis by a multi-center, superiority diagnostic study.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: March 1, 2021
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Encephalitis
• Headache
• Meningitis
• Meningitis/Encephalitis
• Stroke
• Vertigo

Intervention

Device:
• DeepDoc AI-based Decision Support System
Patients are diagnosed by the DeepDoc within 24 hours of admission.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

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