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Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

NCT ID: NCT05792475

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Breast Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Define Standard of Truth (SOT) by 3 experts

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

Group Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases.

Interventions

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

TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TaiHao Medical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TaiHao Medical Inc

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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TaiHao TVGH2020-07-006AC#1

Identifier Type: -

Identifier Source: org_study_id