Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

November 22, 2023 updated by: TaiHao Medical Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10663
        • TaiHao Medical Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Define Standard of Truth (SOT) by 3 experts
Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
Time Frame: 1 week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.
Time Frame: 1 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TaiHao Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

June 14, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TaiHao TVGH2020-07-006AC#1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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