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
1 other identifier
observational
4,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedDecember 13, 2019
July 1, 2019
8 days
August 4, 2019
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of diagnosis by DeepDoc AI-based Decision Support System
Accuracy of diagnosis by DeepDoc and compare this result with doctors
24 hours
Secondary Outcomes (2)
Sensitivity of diagnosis by DeepDoc AI-based Decision Support System
24 hours
Specificity of diagnosis by DeepDoc AI-based Decision Support System
24 hours
Study Arms (4)
Meningitis/Encephalitis
Patients with clinical signs and symptoms suspected of meningitis/encephalitis
Stroke
Patients with clinical signs and symptoms suspected of stroke
Headache
Patients with clinical signs and symptoms suspected of headache
Vertigo
Patients with clinical signs and symptoms suspected of vertigo
Interventions
Patients are diagnosed by the DeepDoc within 24 hours of admission.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients discharged, transferred to the hospital, or died within 24 hours after admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhao Gang
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2019
First Posted
August 14, 2019
Study Start
September 1, 2020
Primary Completion
September 9, 2020
Study Completion
March 1, 2021
Last Updated
December 13, 2019
Record last verified: 2019-07