CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Reader Group X - Session 1 +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04551105N/ACompleted
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Evaluation of TaiHao Breast Ultrasound Diagnosis Software

TaiHao Medical Inc.·interventional·Posted Sep 16, 2020·Updated Nov 2, 2022

In Brief

A clinical study evaluating Reader Group X - Session 1, Reader Group Y - Session 1, and 2 other interventions for Breast Cancer and Breast Diseases. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Diseases
CountriesUnited States
CollaboratorsColumbia University, Taipei Veterans General Hospital, Taiwan, Virginia Polytechnic Institute and State University

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartAug 15, 2020
Primary CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.8 years ago

Interventions

Reader Group X - Session 1other

Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.

Reader Group Y - Session 1other

Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.

Reader Group X - Session 2other

Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.

Reader Group Y - Session 2other

Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.