Evaluation of the Effect of Body Position and Probe Position on the Localization of Breast Mass in Free-Hand Breast Ultrasound Examination
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- movement of a given ultrasound breast lesion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •21-70 years of age
- •Known palpable or non-palpable benign or probably benign breast mass or masses, less than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous ultrasound examination
排除标准
- •Women with cardiac pacemaker or portable defibrillator
- •Women with known breast cancer or suspicious lesions
- •Pregnant and lactating women
- •Women who have breast implant(s)
- •Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass.
- •Women with the target finding to be mapped within a distance of 4 cm from patient's nipple.
- •Women with multiple similar qualifying targets in close proximity (less than 4 cm between targets).
- •Women with history of allergy to medical-grade adhesive tape or ultrasound gel
- •Women whose weight is over 250 pounds
结局指标
主要结局
movement of a given ultrasound breast lesion
时间窗: study completion, an average of 1 day
movement of a given ultrasound breast lesion between different operators and between different body rotation positions and probe positions and orientations
次要结局
未报告次要终点