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临床试验/NCT00792961
NCT00792961已完成不适用

In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study

Peter Delaney2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Peter Delaney
入组人数
10
试验地点
2
主要终点
Endomicroscopy images captured from prostate and surrounding tissues

研究概览

简要总结

The study involves use of a device called an endomicroscope to obtain high resolution images of microscopic structures during robot-assisted prostate cancer surgery. This feasibility study is largely descriptive, and will use endomicroscopy to document the cellular and architectural appearance of tissue during minimally invasive prostate surgery for later comparison with features seen upon conventional histopathological examination of biopsies or resection specimens.

详细描述

Prostate surgery requires meticulous dissection around nerves and associated structures such as the bladder, seminal vesicles and vas deferens. Nerve damage during prostatectomy can result in undesirable outcomes such as impotence and urinary incontinence. Robot assisted minimally invasive prostatectomy offers enhanced visualisation of the surgical field. Superior clinical outcomes in terms of length of hospital stay, blood loss, and oncologic margins compared with open surgery are reported. Confocal endomicroscopy provides high resolution subsurface cellular imaging in real time and is already in clinical use in gastroenterology and under investigation in other surgical applications. A potential role exists for confocal endomicroscopy to enhance microscopic nerve identification intra-operatively and guide surgical decision making during robot-assisted prostatectomy.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy

排除标准

  • Patients under 18 years of age
  • Patients with allergy or prior adverse reaction to Fluorescein Sodium
  • Patients unable to give informed consent

结局指标

主要结局

Endomicroscopy images captured from prostate and surrounding tissues

时间窗: During surgery

次要结局

  • Comparison with conventional histology from corresponding biopsies or resection specimens(Post-surgery, after pathologist's review)

研究者

发起方
Peter Delaney
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Peter Delaney

Director of Technology

Optiscan Pty Ltd

研究点 (2)

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