NCT01692405已完成不适用
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- percent of tissue loss
研究概览
简要总结
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
- Biopsy core length obtained (i.e. collecting all tissue fragments)
- Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
- Pathologist interpretability
- Processing time
- Prostate cancer detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure.
- •Signed informed consent.
排除标准
- •Patient's unwilling to participate.
研究组 & 干预措施
Standard method
No Intervention
Standard method- shaking the biopsy needle into a formalin container.
Download onto a biopsy sponge pad
Active Comparator
Samples will be downloaded by moving the needle notch on a biopsy sponge pad.
干预措施: biopsy sponge pad (Procedure)
Dowloading the biopsy cores using NavigoBx system
Experimental
Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.
干预措施: NaviGo Bx™ (Device)
结局指标
主要结局
percent of tissue loss
时间窗: 1 year
percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide
次要结局
- processing time(1 year)
- prostate cancer detection rate(1 year)
研究者
研究点 (1)
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