Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-29 @ 1:12 PM
Study NCT ID:
NCT04055766
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2019-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Diagnostic Test on DeepDoc-an AI-based Decision Support System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D004660', 'term': 'Encephalitis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2019-08-04', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of diagnosis by DeepDoc AI-based Decision Support System', 'timeFrame': '24 hours', 'description': 'Accuracy of diagnosis by DeepDoc and compare this result with doctors'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of diagnosis by DeepDoc AI-based Decision Support System', 'timeFrame': '24 hours', 'description': 'Sensitivity of diagnosis by DeepDoc and compare this result with doctors'}, {'measure': 'Specificity of diagnosis by DeepDoc AI-based Decision Support System', 'timeFrame': '24 hours', 'description': 'Specificity of diagnosis by DeepDoc and compare this result with doctors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence'], 'conditions': ['Stroke', 'Headache', 'Vertigo', 'Meningitis/Encephalitis']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache.\n2. Neurological examination results and imaging changes within 24 hours of admission.\n\nExclusion Criteria:\n\nPatients discharged, transferred to the hospital, or died within 24 hours after admission.'}, 'identificationModule': {'nctId': 'NCT04055766', 'briefTitle': 'A Diagnostic Test on DeepDoc-an AI-based Decision Support System', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'DeepDoc - Clinical Validation of an AI-based Decision Support System in the Early Diagnostic Evaluation of Neurological Diseases: a Prospective Multi-center Study', 'orgStudyIdInfo': {'id': 'DeepDoc-M5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Meningitis/Encephalitis', 'description': 'Patients with clinical signs and symptoms suspected of meningitis/encephalitis', 'interventionNames': ['Device: DeepDoc AI-based Decision Support System']}, {'label': 'Stroke', 'description': 'Patients with clinical signs and symptoms suspected of stroke', 'interventionNames': ['Device: DeepDoc AI-based Decision Support System']}, {'label': 'Headache', 'description': 'Patients with clinical signs and symptoms suspected of headache', 'interventionNames': ['Device: DeepDoc AI-based Decision Support System']}, {'label': 'Vertigo', 'description': 'Patients with clinical signs and symptoms suspected of vertigo', 'interventionNames': ['Device: DeepDoc AI-based Decision Support System']}], 'interventions': [{'name': 'DeepDoc AI-based Decision Support System', 'type': 'DEVICE', 'description': 'Patients are diagnosed by the DeepDoc within 24 hours of admission.', 'armGroupLabels': ['Headache', 'Meningitis/Encephalitis', 'Stroke', 'Vertigo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhao Gang', 'role': 'CONTACT', 'email': 'zhaogang@fmmu.edu.cn', 'phone': '02984775368'}], 'overallOfficials': [{'name': 'Zhao Gang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}