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CT Image-assisted Detection Software for Focal Liver Lesions

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06068413
Acronym
MRMC
Enrollment
376
Registered
2023-10-05
Start date
2023-04-01
Completion date
2024-04-30
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Liver Lesion

Keywords

CT image-assisted detection software, focal liver lesion

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.

Interventions

DEVICECT image-assisted detection software

CT image-assisted detection software can help doctor to diagnosis the focal liver lesion

Sponsors

Ningbo No.2 Hospital
CollaboratorOTHER
Shenzhen Sixth People's Hospital
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
AFROC1 yearUnder 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026