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)
Loading locations...
相似试验
已完成
不适用
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy SystemBreast Cancer FemaleNCT03300206Hologic, Inc.525
已完成
不适用
Evaluation of the SmartBx System for Breast BiopsyBreast CancerNCT03808116UC Care, Ltd.30
招募中
不适用
Clinical Data Collection in Breast Tomosynthesis (COBRIS)Breast CancerNCT05914168GE Healthcare150
已完成
不适用
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal SyndromeAromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)Breast CancerNCT03665077University of Arizona28
已完成
不适用
The Tomosynthesis Trial in Bergen - Part 2Breast NeoplasmsNCT03669926Norwegian Institute of Public Health31,082