In Vivo Smart Biopsy Device Protocol In Radiology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Correlation between pathology results and device readings
研究概览
简要总结
This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.
详细描述
This is a single arm, multicenter study. It will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast.
The study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 18 years of age
- •Undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast
- •Signed Informed Consent Form
排除标准
- •Concurrent infectious disease
- •Pregnancy or breastfeeding
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
- •Implanted devices / Implants in the operated breast
结局指标
主要结局
Correlation between pathology results and device readings
时间窗: 2-3 weeks following biopsy procedure
Correlation between pathology results and device readings
Ergonomic Assessment of the Smart Biopsy Device
时间窗: At the day of the biopsy procedure
A questionnaire will be completed by the radiologist and applicable radiology lab staff to assess the ease of device assembly and handling properties. Each of the eight questions will use the same four point rating scale. At the end of the study the average and standard deviation will be calculated for each of the questions.
Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs)
时间窗: The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure
AEs will be documented during the biopsy procedure and SAEs will be followed up to 3 weeks after the biopsy procedure. Rates of adverse events such as bleeding, hematoma, infection and pain will be compared to adverse events for similar procedures published in the literature and anticipated in the product risk analysis.
次要结局
未报告次要终点