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Clinical Trials/NCT00792961
NCT00792961
Completed
Not Applicable

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

Peter Delaney1 site in 1 country10 target enrollmentNovember 2008
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Peter Delaney
Enrollment
10
Locations
1
Primary Endpoint
Endomicroscopy images captured from prostate and surrounding tissues
Status
Completed
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
December 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Peter Delaney

Director of Technology

Optiscan Pty Ltd

Eligibility Criteria

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

Outcomes

Primary Outcomes

Endomicroscopy images captured from prostate and surrounding tissues

Time Frame: During surgery

Secondary Outcomes

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

Study Sites (1)

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