NCT02997540

Effect of Body Position and Probe Position on the Localization of Breast Mass

Evaluation of the Effect of Body Position and Probe Position on the Localization of Breast Mass in Free-Hand Breast Ultrasound Examination

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: MetriTrack, Inc. · Industry
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination.

Detailed description

The proposed research consists of quantitatively detecting and reporting the effect of body rotation and ultrasound probe position on the breast on the position of breast lesions relative to the breast nipple and body orientation planes, required for positional annotations, in female subjects at one study visit. Measurements will be manually and automatically recorded by two ultrasound operators with each image and will be compared among these conditions to detect effects of probe position and probe orientation and patient's body position relative to the exam table. The manual and automated measurements will be compared to determine the differences between the data obtained using the two different methods.

Conditions

• Breast Diseases

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-12-20
• Last updated: 2021-07-21

Locations

1 site across 1 country: United States