Prostate Biopsy Access Needle & Needle Guide Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Perineologic
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Assessment of the handling characteristics of the access needle and needle guide.
研究概览
简要总结
The objective of the study is to assess the design features of a modified stainless steel access needle (single use disposable) in a clinical setting and a disposable, single use, custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. The disposable stainless steel access needle may be used with or without the disposable needle guide, but will always be used with ultrasound image guidance and a biopsy gun. The primary purpose of the single-use disposable access needle is to guide the use of a biopsy gun to obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of the perineum. The primary purpose of the disposable needle guide is to stabilize the needle biopsy and better approximate the most direct path to the prostate.
详细描述
The objective of the study is to assess the design features of a modified stainless steel access needle (single use disposable) in a clinical setting with and a disposable, single use, custom-made, polymer needle guide used in conjunction with a rectal ultrasound probe. The disposable stainless steel access needle may be used with or without the disposable needle guide, but will always be used with ultrasound image guidance and a biopsy gun. The primary purpose of the single-use disposable access needle is to guide the use of a biopsy gun to obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of the perineum. The primary purpose of the disposable needle guide is to stabilize the needle biopsy and better approximate the most direct path to the prostate. For some subjects, the study will assess the fit and functionality of the stainless steel access needle when used in conjunction with the disposable needle guide as well as multiple handling aspects of the access needle and disposable needle guide when utilized in a prostate biopsy procedure. The study will also assess the ability of trans-rectal ultrasound to appropriately image the stainless steel access needle and biopsy gun needle at, near, and within the prostate tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Males requiring a needle-biopsy of the prostate with ultrasound assistance via a trans-rectal ultrasound probe
- •Otherwise healthy patient with no serious acute or chronic illness
排除标准
- •Patients with a partial or complete prostectomy
- •Patients with active infection of the prostate, perineum, rectum, bowel, or peritoneum
- •Patients with serious acute or chronic illness
- •Cannot read and comprehend simple instructions in English
- •Poorly controlled psychiatric disease
结局指标
主要结局
Assessment of the handling characteristics of the access needle and needle guide.
时间窗: The time point at which this will be measured is at the end of the prostate biopsy procedure up to 30 days through study completion.
Assessment of the handling characteristics of the single use, disposable stainless steel access needle and the single use, disposable polymeric needle guide will be completed by the user completing a questionnaire rating various performance characteristics of the access needle and the needle guide at the completion of each prostate biopsy. Using a scale from 1 to 5, with 1 being poor and 5 being excellent, each characteristic of the access needle and the needle will be rated. The results will be summarized across all characteristics and reported as percentages of each rating scale indicator, 1 through 5.
次要结局
未报告次要终点