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Trial Title:
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
NCT ID:
NCT05792475
Condition:
Breast Cancer
Breast Diseases
Conditions: Official terms:
Breast Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
Description:
TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT)
about108 cases.
Arm group label:
Define Standard of Truth (SOT) by 3 experts
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
69 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
TaiHao Medical Inc
Address:
City:
Taipei
Zip:
10663
Country:
Taiwan
Start date:
January 30, 2023
Completion date:
November 30, 2023
Lead sponsor:
Agency:
TaiHao Medical Inc.
Agency class:
Industry
Source:
TaiHao Medical Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05792475
