Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

TaiHao Medical

Status: Active, not recruiting

Conditions: Breast Cancer; Breast Diseases

Treatments: Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software

Study type: Interventional

Funder types: Industry

Identifiers

NCT05792475

TaiHao TVGH2020-07-006AC#1

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Define Standard of Truth (SOT) by 3 experts

Other group

Description:

Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.

Treatment:

Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software