NCT05946759已完成不适用
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Reoperation Rate
研究概览
简要总结
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Adult female Subject ≥18 years old.
- •Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.
- •Subject is able to read, understand and sign the informed consent.
排除标准
- •Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.
- •Subject with previous radiotherapy of the ipsilateral breast.
- •Subject with multicentric/multilateral breast cancer.
- •Subject with planned mastectomy, tumor-adapted breast reduction.
- •Subject with pre-surgical/ preoperative neo-adjuvant treatment.
- •Subject is pregnant/ lactating.
- •Participation in any other clinical study that would affect data acquisition.
结局指标
主要结局
Reoperation Rate
时间窗: 2-30 days post Breast Surgery
Differences in the rate of reoperation due to cancer positive margins
次要结局
- Change in hospital cost with or without IVD device and accessories [Economic Impact](30 days post surgery date)
- System Usability Scale (SUS) of the IVD device and accessories [Usability](Only during the time of the breast surgery)
- Incidence of adverse device effects [Safety](Only during the time of the breast surgery)
- Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance](0-30 days post Breast Surgery)
研究者
研究点 (1)
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