Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Prostate biopsy length (measured by pathologist)
研究概览
简要总结
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.
详细描述
Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer.
Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard 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. All biopsies are taken from behind the back of the patient enabling masking from the patient. To assess masking success, patients will be asked to guess which device was used after the procedure is complete.
入排标准
- 年龄范围
- 40 Years 至 —（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 contraindications for prostate biopsy or patient not willing to participate)
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 fragmentation(within 21 days post biopsy)
- General appearance of biopsy assessed by pathologist (biopsy quality)(within 21 days post biopsy)
- Prostate biopsy length (measured after removal from biopsy chamber)(within 21 days post biopsy)
- Prostate biopsy length (measured in biopsy needle chamber)(within 21 days post biopsy)