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Completed

NCT Number: NCT00792961

Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital at Westlake Medical Center

Austin, Texas, 78746, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endomicroscopy

Device

Rigid drop-in endomicroscope imaging probe

Primary outcomes

  1. Endomicroscopy images captured from prostate and surrounding tissues

    Time frame: During surgery

Secondary outcomes

  1. Comparison with conventional histology from corresponding biopsies or resection specimens

    Time frame: Post-surgery, after pathologist's review

Sponsors and collaborators

Lead sponsor

Peter Delaney

Industry

Collaborators

  • Hospital at Westlake

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 18, 2008
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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