Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endomicroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Robotic surgery, Endomicroscopy
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
Sites / Locations
- The Hospital at Westlake Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endomicroscopy
Arm Description
Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery
Outcomes
Primary Outcome Measures
Endomicroscopy images captured from prostate and surrounding tissues
Secondary Outcome Measures
Comparison with conventional histology from corresponding biopsies or resection specimens
Full Information
NCT ID
NCT00792961
First Posted
November 16, 2008
Last Updated
April 7, 2014
Sponsor
Peter Delaney
Collaborators
Hospital at Westlake
1. Study Identification
Unique Protocol Identification Number
NCT00792961
Brief Title
Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
Official Title
In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Delaney
Collaborators
Hospital at Westlake
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Robotic surgery, Endomicroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endomicroscopy
Arm Type
Experimental
Arm Description
Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery
Intervention Type
Device
Intervention Name(s)
Endomicroscopy
Intervention Description
Rigid drop-in endomicroscope imaging probe
Primary Outcome Measure Information:
Title
Endomicroscopy images captured from prostate and surrounding tissues
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Comparison with conventional histology from corresponding biopsies or resection specimens
Time Frame
Post-surgery, after pathologist's review
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Fagin, MD
Organizational Affiliation
The Hospital at Westlake Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Delaney, BSc
Organizational Affiliation
Optiscan Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
The Hospital at Westlake Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
12. IPD Sharing Statement
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Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
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