NCT04551105

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: TaiHao Medical Inc. · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Reader Group X - Session 1	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.
DIAGNOSTIC_TEST	Reader Group Y - Session 1	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.
DIAGNOSTIC_TEST	Reader Group X - Session 2	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.
DIAGNOSTIC_TEST	Reader Group Y - Session 2	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.

Timeline

• Start date: 2020-08-15
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2020-09-16
• Last updated: 2022-11-02
• Results posted: 2022-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study