Confocal Histolog Scanner in Routine Breast-Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reoperation Rate
研究概览
简要总结
The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.
详细描述
Breast cancer is the most common cancer in women. Moreover, numerous women have the diagnosis of a ductal carcinoma in situ (DCIS) each year, which can develop to invasive breast cancer without therapy. Breast conserving surgery (BCS) is the most performed surgical treatment for women with early-stage breast cancer and/ or DCIS. There is an ongoing need for more immediate and accurate methods for the intraoperative assessment (IOA) of breast tissue margins to achieve tumor free margins. A method for rapidly and accurately identifying positive surgical margins intraoperatively would allow the surgeon to immediately excise additional tissue to achieve negative margins. Thereby sparing the Subject a reoperation with all following consequences i.e., reduced oncological safety, reduced cosmetic, and economic burden. The Histolog® Scanner (HLS), a confocal laser scanning microscope was developed with the CE Mark intended use of imaging excised human tissue specimens to visualize morphological microstructures. Such a feature allows real-time IOA offering cutting edge imaging support beyond the conventional imaging techniques in clinical decision making. Promising results have been previously obtained in the SENOSI study of Sion (Switzerland) and the POLARHIS and HELIXIR studies in Germany. Therefore, this study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when the HLS is used in the context of breast tissue margin assessment.
Primary Objective:
Evaluate the proportion of patients that had a surgical reoperation due to cancer-positive margins (Reoperation Rate).
Secondary Objectives:
Detection Rate
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female Subject ≥18 years old.
- •Subject scheduled for breast conserving surgery of invasive and/or in-situ ductal and lobular carcinoma.
- •Subject is able to read, understand and sign the informed consent.
排除标准
- •Subject with planned mastectomy
- •Subject does not speak French- Subject with planned tumor-adapted breast reduction
- •Subject is pregnant/ lactating. Subjects pregnant/lactating are excluded because such subjects are presenting additional risks during the surgery and they are also rare.
- •Participation in any other clinical study that would affect data acquisition.
结局指标
主要结局
Reoperation Rate
时间窗: From enrollment to the end of treatment (surgery) at 1 month
Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
次要结局
- Detection Rate(1 year)
- Usability(1 year)
- Economic Impact(1 year)
- Incidence of adverse device effects(14 month)
- Detection Rate(1 year)
- Usability(1 year)
- Incidence of adverse device effects(14 month)
- Economic Impact(1 year)