NCT06068413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

February 10, 2025

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

September 28, 2023

Last Update Submit

February 5, 2025

Conditions

Focal Liver Lesion

Keywords

CT image-assisted detection softwarefocal liver lesion

Outcome Measures

Primary Outcomes (1)

  • AFROC

    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

    1 year

Study Arms (2)

AI-assisted diagnosis

EXPERIMENTAL

Doctors diagnose the focal liver lesion with the help of AI.

Device: CT image-assisted detection software

common diagnosis

NO INTERVENTION

Doctors diagnose the focal liver lesion without the help of AI.

Interventions

CT image-assisted detection softwareDEVICE

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

AI-assisted diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 5, 2023

Study Start

April 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

February 10, 2025

Record last verified: 2023-04

Locations

CN(1)