跳至主要内容
临床试验/NCT01102361
NCT01102361Unknown1 期

Study of Prostate Cancer Detection With in House Developed Robot

Singapore General Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
1 期
入组人数
250
试验地点
2
主要终点
Cancer Detection

研究概览

简要总结

The objective of the study is to examine the effectiveness and accuracy of the BioXbot in prostate biopsy as opposed to transrectal biopsy. This evaluation of the efficacy of both the procedures is based on:

  • Uptake rate
  • Peripheral zone reachability
  • Needling accuracy
  • Procedure execution time
  • Post operative discomfort or trauma experienced by patient
  • Quality and type of tissue sample extracted
  • Adverse and unanticipated side-effects on patient after the procedure and recording any unexpected reactions

详细描述

The prostate gland is a walnut-sized organ found only in men that encircles the urethra (urine passage) below the urinary bladder. It secretes fluid that is an important component of semen. Prostate cancer is a disease of the prostate gland where malignant tumours cells invade normal prostate tissue and spread to other organs. It is second leading cause of cancer death in men and it is mainly found in men above the age of 50 years.

Prostate biopsy is considered to be the most definitive diagnostic tool for prostate cancer. It is a surgical procedure in which a small sample of tissue is removed from the prostate gland and examined by a pathologist. The procedure normally takes about 15 minutes and is usually performed by the urologist in conjunction with transrectal ultrasound (TRUS). No anesthetic is required. With the help of TRUS, a doctor guides a biopsy gun -- a hand-held device with a spring-loaded, slender needle -- through the wall of the rectum into the area of the prostate gland that appears abnormal. Since the rectal wall is thin, it is possible to place the needle more accurately and with less injury to other tissues. When activated, the needle can remove a slender cylinder of tissue, called a core.

Transrectal ultrasound-guided prostate biopsy has become the standard for obtaining tissue for the histological diagnosis of prostate cancer. On the other hand, transperineal approach is not commonly used worldwide and little data is available on transperineal prostate biopsy.

However, there are some problems with existing system and these include:

  • Random Biopsy Sites: Biopsy cores represent only about 0.6% of the prostate in terms of volume. Therefore, without having accurate knowledge of cancer sites, it is unlikely that a random biopsy protocol will yield consistently high cancer detection rates.
  • Inaccurate Needling: The biopsy needle may not reach the desired position accurately and quickly under manual control.
  • Limited 2D Guidance: The TRUS used for biopsy guidance is 2D ultrasound images. As the biopsy sites are distributed in 3D, it is difficult for the surgeon to imagine the overall picture of the biopsy sites and identify the biopsy site accurately and intuitively.
  • Risk Factors: The two primary risks of needle biopsy are severe bleeding and infection of the prostate gland or urinary tract.
  • Transrectal Shortfalls: As most of the cancer occurs at the apex area of the prostate, transperineal biopsy is considered having higher chance to get cancer tissue, comparing with the conventional transrectal biopsy. Furthermore, transperineal biopsy is considered "cleaner", as its puncture point is on skin, rather than on rectum.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • At least one normal previous prostate biopsy and at least 2 weeks since prior prostate biopsy
  • Increasing prostate-specific antigen (PSA) level
  • The Investigator has completed a medical history and a physical examination to assure that the subjects meet all study enrollment criteria

排除标准

  • Patient with operative risk ASA ( American Society of Anaesthesia) = or > 4
  • A history of bleeding disorders/coagulopathy or ongoing treatment for this condition
  • Patients with psychiatric diseases or insufficient cerebral function

结局指标

主要结局

Cancer Detection

时间窗: 2 years

to detect any undetected cancer in Patietns undergoing saturation biopsy

次要结局

  • Accuracy and Repeatability(6 months)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验