A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Procedure Success
研究概览
简要总结
Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.
详细描述
This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Scheduled for a prostate biopsy
- •Able and willing to provide verbal assessment of his condition 5 days post-procedure
排除标准
- •Unable or unwilling to provide consent
结局指标
主要结局
Procedure Success
时间窗: 1 Day of the procedure
Percentage of tissue samples suitable for pathological review
Adverse Events
时间窗: 1 Day of the procedure
Incidence and Severity of Adverse events associated with use of the biopsy needles
Patient Pain During use of the biopsy needles
时间窗: 1 Day of the procedure
Pain measured with Likert Scale of 1 to 5
次要结局
- Mean Tissue volume for each sample taken(1 Day of the procedure)