Prospective Patient Blinded Randomized Trial Comparing Biopsy Specimen Quality in a Novel Biopsy Needle and Actuator Compared to Todays Standard Tru Cut Needle and Actuator.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- prostate biopsy length (measured by pathologist)
研究概览
简要总结
Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.
详细描述
Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance.
The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today.
This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient and pathologist are unaware of which needle/device is used. TRUSbx are taken from behind the back of the patient enabling masking from the patient.
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Eligible for prostate biopsy
- •Signed informed written consent
排除标准
- •None (other than general contra indications for prostate biopsy or patient not willing to participate)
研究组 & 干预措施
standard tru cut needle
TRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient.
干预措施: TRUSbx (Device)
novel needle
TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient.
干预措施: TRUSbx (Device)
结局指标
主要结局
prostate biopsy length (measured by pathologist)
时间窗: within 21 days post biopsy
Length of biopsy specimen in millimeters
次要结局
- prostate biopsy length (measured in after removal from biopsy chamber)(within 21 days post biopsy)
- prostate biopsy fragmentation(within 21 days post biopsy)
- General appearance of biopsy assessed by pathologist (biopsy quality)(within 21 days post biopsy)
- prostate biopsy length (measured in biopsy needle chamber)(within 21 days post biopsy)