Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

• Sponsor: TaiHao Medical Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05792475
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Breast Diseases	Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
• Actual Study Start Date: Jan 30, 2023
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance. [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.

Secondary Outcome Measures

1. The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 69 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TaiHao Medical Inc	Taipei		Taiwan	10663

Sponsors and Collaborators

• TaiHao Medical Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 27, 2023

More Information

Publications

None provided.

• Responsible Party: TaiHao Medical Inc.
• ClinicalTrials.gov Identifier: NCT05792475
• Other Study ID Numbers: TaiHao TVGH2020-07-006AC#1
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Breast Diseases

Study Results

No Results Posted as of Mar 31, 2023