Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

This study has been completed.
Sponsor:
Collaborator:
Hospital at Westlake
Information provided by (Responsible Party):
Peter Delaney, Optiscan Pty Ltd
ClinicalTrials.gov Identifier:
NCT00792961
First received: November 16, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention
Prostate Cancer
Device: Endomicroscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study

Resource links provided by NLM:


Further study details as provided by Optiscan Pty Ltd:

Primary Outcome Measures:
  • Endomicroscopy images captured from prostate and surrounding tissues [ Time Frame: During surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison with conventional histology from corresponding biopsies or resection specimens [ Time Frame: Post-surgery, after pathologist's review ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endomicroscopy
Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery
Device: Endomicroscopy
Rigid drop-in endomicroscope imaging probe

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792961

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

No publications provided

Responsible Party: Peter Delaney, Director of Technology, Optiscan Pty Ltd
ClinicalTrials.gov Identifier: NCT00792961     History of Changes
Other Study ID Numbers: 13082008
Study First Received: November 16, 2008
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Optiscan Pty Ltd:
Prostate cancer
Robotic surgery
Endomicroscopy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014