Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Procedure success
研究概览
简要总结
This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.
详细描述
Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient has BPH requiring a prostate biopsy
- •Able and willing to provide consent
排除标准
- •Active infection
- •Subject participating in an other device study of the prostate
结局指标
主要结局
Procedure success
时间窗: During the procedure
\> 3 mm/cc of tissue collected in each biopsy
Quality of biopsy tissue
时间窗: During the procedure
Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome.
次要结局
- Performance of the study device(During the procedure)