NCT06352684

Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: BeamWorks Inc. · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination

Detailed description

CadAI-B for Breast is a real-time AI diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	CadAI-B for Breast	CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.

Timeline

• Start date: 2023-11-24
• Primary completion: 2025-01-14
• Completion: 2025-01-14
• First posted: 2024-04-08
• Last updated: 2024-04-08

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study