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临床试验/NCT02001597
NCT02001597已完成不适用

Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy

University of British Columbia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Time required to register the trans-rectal ultrasound coordinates to the da Vinci coordinates

研究概览

简要总结

Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment for prostate cancer. The state of the art radical prostatectomy involves a robotic laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D visualization of the surgical site and improved dexterity over standard laparoscopic instruments. While the long term prognosis of prostate cancer patients who undergo radical prostatectomy has improved significantly over the past two decades, there remain significant rates of disease recurrence and complications.

The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be deployed and used easily during surgery, can be registered to the robot coordinate systems with high accuracy, and can be controlled from the surgeon's console, in order to improve the visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer probability map that can be used to make decisions on surgical margins.

The investigators objectives are

  1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical prostatectomy
  2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate and peri-prostatic tissue from the surgical console

This is an observational study; trans-rectal ultrasound will be used to visualize the prostate and periprostatic structures during surgery but the standard of care will not be affected by this ultrasound imaging.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • All men who undergo robot-assisted radical prostatectomy are eligible.

排除标准

  • 未提供

结局指标

主要结局

Time required to register the trans-rectal ultrasound coordinates to the da Vinci coordinates

时间窗: 1 year

We will measure and report the time required to carry out the registration of the ultrasound transducer relative to the da Vinci coordinate system for each of the patients.

次要结局

  • Successful prostate visualization(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Septimiu E. Salcudean

Professor

University of British Columbia

研究点 (1)

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