Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

April 7, 2014 updated by: Peter Delaney

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78746
        • The Hospital at Westlake Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endomicroscopy images captured from prostate and surrounding tissues
Time Frame: During surgery
During surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison with conventional histology from corresponding biopsies or resection specimens
Time Frame: Post-surgery, after pathologist's review
Post-surgery, after pathologist's review

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Delaney

Collaborators

Hospital at Westlake

Investigators

  • Principal Investigator: Randy Fagin, MD, The Hospital at Westlake Medical Center
  • Study Director: Peter Delaney, BSc, Optiscan Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

November 16, 2008

First Submitted That Met QC Criteria

November 16, 2008

First Posted (ESTIMATE)

November 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13082008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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