A Retrospective, Multicenter, Multiple-viewer-multiple-case (MRMC) Clinical Trial to Evaluate the Safety and Efficacy of CT Image-assisted Detection Software for Focal Liver Lesions

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country376 target enrollmentApril 1, 2023

ConditionsFocal Liver Lesion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Focal Liver Lesion
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 376
Locations: 1
Primary Endpoint: AFROC
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the safety and effectiveness of the developed and produced CT image-assisted detection software for focal liver lesions before being put into the market.

Registry

clinicaltrials.gov

Start Date

April 1, 2023

End Date

April 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•doctors have liver CT scanning experience more than 1 year;

Exclusion Criteria

•persons don't have the license of practicing physician; doctors don't have liver CT scanning experience or have liver CT scanning experience less than 1 year;

Outcomes

Primary Outcomes

AFROC

Time Frame: 1 year

Under different confidence scores, the number of accurately located lesions/the number of true lesions determined by the reference standard was taken as the ordinate coordinate, and (1- the number of negative cases determined by the reference standard/the total number of true negative cases diagnosed by the reference standard) was plotted as the horizontal coordinate