Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

NCT ID: NCT00792961

Last Updated: 2014-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Endomicroscopy

Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery

Group Type: EXPERIMENTAL

Endomicroscopy

Intervention Type: DEVICE

Rigid drop-in endomicroscope imaging probe

Interventions

Endomicroscopy

Rigid drop-in endomicroscope imaging probe

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital at Westlake

UNKNOWN

Sponsor Role: collaborator

Peter Delaney

INDUSTRY

Sponsor Role: lead

Responsible Party

Peter Delaney

Director of Technology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Randy Fagin, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital at Westlake Medical Center

Peter Delaney, BSc

Role: STUDY_DIRECTOR

Optiscan Pty Ltd

Locations

The Hospital at Westlake Medical Center

Austin, Texas, United States

Countries

United States

Other Identifiers

13082008

Identifier Type: -

Identifier Source: org_study_id