STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- Number of Participants Invasive Visits
研究概览
简要总结
This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.
详细描述
This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits to the breast center for invasive procedures between biopsy and surgery, and quantify this value to the public healthcare system. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman >18 years and < 80 years of age;
- •Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5;
- •Lesion depth is < 6 cm from skin surface;
- •Non-palpable lesions;
- •Informed consent obtained.
排除标准
- •Multicentric breast cancer;
- •Pregnant or lactating;
- •Known or suspected nickel-titanium allergy.
结局指标
主要结局
Number of Participants Invasive Visits
时间窗: through study completion, an average of 6 months
Number of visits to the breast centre for an invasive procedure between biopsy and surgery
次要结局
- Performance(through study completion; an average of 6 months)
- Number of Participants With Adverse Events(through study completion; an average of 6 months)