NCT03456583已完成不适用
A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Procedural Time
研究概览
简要总结
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Female aged 18 years of age or older
- •Subject has at least one breast imaging finding requiring biopsy for which images are available
- •Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her
排除标准
- •Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy.
- •Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.
结局指标
主要结局
Procedural Time
时间窗: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Total time elapsed between from when the subject enters the procedure room until she has left the procedure room.
次要结局
- Post-biopsy Complication Rates(Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only)
- Average Number of Cores Per Lesion(Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only)
- Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient(Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only)
研究者
研究点 (6)
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