Clinical Evaluation of CEM-guided Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Image visibility of enhancing finding
研究概览
简要总结
CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (FNA). This device cannot be used for reasons other than its intended use.
This evaluation is being done to learn more about the CEM-guided biopsy. Clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.
详细描述
Pristina Serena CEM is an option to the standard Pristina Serena breast biopsy unit. It is designed to allow the accurate localization of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. It is intended to provide guidance for histological purposes such as core or vacuum-assisted biopsies, for pre-surgical localization procedures, or Fine Needle Aspiration (FNA) for cytopathology analysis.
The main purpose of this evaluation is to collect feedback to assess image readability and look-and feel, usability, workflow and user preference information from physicians and technologists who use CEM-guided biopsy to perform minimally invasive interventional breast procedures under clinical conditions. All feedbacks are collected by observations, interviews and surveys.
The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
- •Are able and willing to comply with study procedures
- •Are able and willing to provide written informed consent to participate
排除标准
- •Findings not accessible for stereotactic guidance biopsy
- •Are currently lactating
- •Have breast implants
结局指标
主要结局
Image visibility of enhancing finding
时间窗: immediately after each CEM-guided biopsy
To assess the visibility of an index enhancing finding at the point of the CEM-guided biopsy. The enhancement in the biopsy images will be compared to the enhancing lesion initially detected at the diagnostic CEM examination, that led to the prescription of the breast biopsy. It is a subjective and dichotomous measure: visible or not visible.
次要结局
- Number of participants with CEM-guided biopsy minor complications.(immediately after each CEM-guided biopsy)
- Biopsy needle approach(immediately after each CEM-guided biopsy)
- Pathology results on biopsy specimen(up to 3 weeks)
- Upgrade rate to malignancy of biopsied lesions that underwent surgical or percutaneous intervention(an average of 3 months)
- Total time per procedure(immediately after each CEM-guided biopsy)