A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 525
- 试验地点
- 7
- 主要终点
- Difference in Procedural Time in Minutes
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 as compared to the current standard-of-care breast biopsy procedures
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
- •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
Difference in Procedural Time in Minutes
时间窗: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.
The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.
次要结局
- Post-biopsy Complication Rates(The time of consent until the subject procedure was completed, an average of 1 day)
- Number of Samples Collected Per Lesion(Samples collected from day of Breast Biopsy Procedure Only)
- Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients(Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only)