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

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Endomicroscopy images captured from prostate and surrounding tissues

Outcome Time Frame:

During surgery

Safety Issue:


Principal Investigator

Randy Fagin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital at Westlake Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

August 2009

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Robotic surgery
  • Endomicroscopy
  • Prostatic Neoplasms



The Hospital at Westlake Medical Center Austin, Texas  78746