NCT00380952已完成不适用
MAST Study Protocol
Dune Medical Devices9 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 9
研究概览
简要总结
This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.
详细描述
Use of the device will take place during a partial mastectomy procedure (lumpectomy).The patient will be randomized to enter the device or control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Women diagnosed with carcinoma of the breast
- •Undergoing lumpectomy (local wide excision) procedure.
- •Over 18 years of age
排除标准
- •Neoadjuvant systemic therapy
- •Previous radiation in the operated breast
- •Prior surgical procedure in the same quadrant
- •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.
研究者
研究点 (9)
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