Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792961
• Other study ID #: 13082008
• Status: Completed
• Phase: N/A
• First received: November 16, 2008
• Last updated: April 7, 2014
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2014
• Source: Optiscan Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Endomicroscopy
Rigid drop-in endomicroscope imaging probe

Locations

Country	Name	City	State
United States	The Hospital at Westlake Medical Center	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Peter Delaney	Hospital at Westlake

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endomicroscopy images captured from prostate and surrounding tissues		During surgery	No
Secondary	Comparison with conventional histology from corresponding biopsies or resection specimens		Post-surgery, after pathologist's review	No