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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05792475
Other study ID # TaiHao TVGH2020-07-006AC#1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date November 30, 2023

Study information

Verified date March 2023
Source TaiHao Medical Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A standard of truth "SOT" is determined based on the interpretation results of the case data by interpretation experts, and the SOT is compared with the detection results of this program's function for detecting suspected breast cancer (CADe function). Estimate the detectability of the CADe function by comparing.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3
Est. completion date November 30, 2023
Est. primary completion date June 14, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 69 Years
Eligibility Inclusion Criteria: - Female patients aged 20 to 69, including those with and without breast lesions. Exclusion Criteria: - Have a pacemaker or prosthetic valve. - A post-surgery follow-up patient.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases.

Locations

Country Name City State
Taiwan TaiHao Medical Inc Taipei

Sponsors (1)

Lead Sponsor Collaborator
TaiHao Medical Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance. The average of 4 types of machines (Canon Aplio i800, GE Logiq E10, GE Invenia ABUS, Fuji ARIETTA 60) performance compared to Siemens performance which was submitted to PMDA last time. 1 week
Secondary The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance. Each machine (Canon Aplio i800, GE Logiq E10, GE Invenia ABUS, Fuji ARIETTA 60) performance compared to Siemens performance which was submitted to PMDA last time. 1 week
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