Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

Breast Cancer Clinical Trial

Official title:

Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05792475
• Other study ID #: TaiHao TVGH2020-07-006AC#1
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases

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