NCT01885741已完成不适用
A Prospective, Open-Label, Single-Arm, Single-Site, Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.
研究概览
简要总结
A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging.
- •Individuals Capable of giving a free and informed consent.
排除标准
- •Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.).
- •Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion.
- •Patients who are not suitable for the procedure will be excluded at the investigators discretion.
- •Patients unwilling to complete associated study questionnaires or follow up visits.
- •Women who are pregnant or who plan to become pregnant within the study duration.
结局指标
主要结局
Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (4)
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