NCT03520127终止不适用
A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
Medtronic Surgical Technologies7 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2017年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 176
- 试验地点
- 7
- 主要终点
- Lesion BIRADS score
研究概览
简要总结
The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •BIRADS ≤ 5, as initially imaged
- •Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used
排除标准
- •Subjects with subglandular (pre-pectoral, or "single plane") breast implants
- •Subjects with electronic implantable devices (such as pacemakers and defibrillators)
- •Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed
结局指标
主要结局
Lesion BIRADS score
时间窗: Weeks prior to the Intact procedure
Diagnostic imaging result
Imaging lesion size
时间窗: Weeks prior to the Intact procedure
Measured in mm
Lesion histology
时间窗: Weeks prior to the Intact procedure
Lesion biopsy results
Tissue margin (as reported from histology) rate
时间窗: Weeks after the Intact procedure, up to approximately 12 weeks
Procedure margin vs. margin size, measured in mm
Underestimation rate
时间窗: Weeks after the Intact procedure, up to approximately 12 weeks
Compared to maximum lesion size, measured in mm
次要结局
未报告次要终点
研究者
研究点 (7)
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