MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 664
- 试验地点
- 36
- 主要终点
- The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.
研究概览
简要总结
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
详细描述
The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women histologically diagnosed with carcinoma of the breast
- •Women with non-palpable malignant lesions, requiring image guided localization.
- •Undergoing lumpectomy (partial mastectomy) procedure.
- •Age 18 years or more
排除标准
- •Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- •Bilateral disease (diagnosed cancer in both breasts)
- •Neoadjuvant systemic therapy
- •Previous radiation in the operated breast
- •Prior surgical procedure in the same breast
- •Implants in the operated breast
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
结局指标
主要结局
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.
时间窗: two weeks after surgery
Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively
次要结局
未报告次要终点