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Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792961
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : April 9, 2014
Hospital at Westlake
Information provided by (Responsible Party):
Peter Delaney, Optiscan Pty Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Endomicroscopy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study
Study Start Date : November 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Endomicroscopy
Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery
Device: Endomicroscopy
Rigid drop-in endomicroscope imaging probe

Primary Outcome Measures :
  1. Endomicroscopy images captured from prostate and surrounding tissues [ Time Frame: During surgery ]

Secondary Outcome Measures :
  1. Comparison with conventional histology from corresponding biopsies or resection specimens [ Time Frame: Post-surgery, after pathologist's review ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792961

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United States, Texas
The Hospital at Westlake Medical Center
Austin, Texas, United States, 78746
Sponsors and Collaborators
Peter Delaney
Hospital at Westlake
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Principal Investigator: Randy Fagin, MD The Hospital at Westlake Medical Center
Study Director: Peter Delaney, BSc Optiscan Pty Ltd

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Responsible Party: Peter Delaney, Director of Technology, Optiscan Pty Ltd Identifier: NCT00792961    
Other Study ID Numbers: 13082008
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by Peter Delaney, Optiscan Pty Ltd:
Prostate cancer
Robotic surgery
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases