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Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis

NCT05320185 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 615

Last updated 2022-09-21

No results posted yet for this study

Summary

With the emergence of advanced technology to date in the artificial intelligence (AI), computer aided diagnosis has gradually gained its popularity in the field of healthcare. Particularly, in the clinical practice of coronary artery disease diagnosis, the application of AI could be of great implication in alleviating the shortage of medical sources. To evaluate the effectiveness and safety of the AI-based coronary CT angiographic analysis software (RuiXin-CoronaryAI) for diagnosis of coronary artery stenosis, a retrospective, multi-center, cross-over designed, blinded, sensitivity superiority and specificity non-inferiority clinical trial will be conducted.

Conditions

Interventions

DEVICE

RuiXin-CoronaryAI software

RuiXin-CoronaryAI, based on Computed Tomography Angiography (CTA) and was independently designed by RaysightMed Inc., which has been already authorized by National Medical Products Administration (NMPA).

Sponsors & Collaborators

  • Tongji Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Shenzhen Raysight Intelligent Medical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Liming Xia · Tongji Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2022-07-30
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320185 on ClinicalTrials.gov