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Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
This study is currently recruiting participants.
Study NCT00792961   Information provided by Optiscan Pty Ltd
First Received: November 16, 2008   Last Updated: November 18, 2008   History of Changes

November 16, 2008
November 18, 2008
November 2008
May 2009   (final data collection date for primary outcome measure)
Endomicroscopy images captured from prostate and surrounding tissues [ Time Frame: During surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00792961 on ClinicalTrials.gov Archive Site
Comparison with conventional histology from corresponding biopsies or resection specimens [ Time Frame: Post-surgery, after pathologist's review ] [ Designated as safety issue: No ]
Same as current
 
Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study

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.

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.

 
Interventional
Diagnostic, Open Label, Single Group Assignment
Prostate Cancer
Device: Endomicroscopy
Experimental: Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
August 2009
May 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Randy Fagin, MD 512-657-6548 randy.fagin@gmail.com
United States
 
NCT00792961
Mr Peter Delaney, Optiscan
13082008
Optiscan Pty Ltd
 
Principal Investigator: Randy Fagin, MD The Hospital at Westlake Medical Center
Study Director: Peter Delaney, BSc Optiscan Pty Ltd
Optiscan Pty Ltd
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP