NCT00792961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

November 16, 2008

Last Update Submit

April 7, 2014

Conditions

Prostate Cancer

Keywords

Prostate cancerRobotic surgeryEndomicroscopy

Outcome Measures

Primary Outcomes (1)

  • Endomicroscopy images captured from prostate and surrounding tissues

    During surgery

Secondary Outcomes (1)

  • Comparison with conventional histology from corresponding biopsies or resection specimens

    Post-surgery, after pathologist's review

Study Arms (1)

Endomicroscopy

EXPERIMENTAL

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

Device: Endomicroscopy

Interventions

EndomicroscopyDEVICE

Rigid drop-in endomicroscope imaging probe

Endomicroscopy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy

You may not qualify if:

  • Patients under 18 years of age
  • Patients with allergy or prior adverse reaction to Fluorescein Sodium
  • Patients unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital at Westlake Medical Center

Austin, Texas, 78746, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Randy Fagin, MD

    The Hospital at Westlake Medical Center

    PRINCIPAL INVESTIGATOR

  • Peter Delaney, BSc

    Optiscan Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Technology

Study Record Dates

First Submitted

November 16, 2008

First Posted

November 18, 2008

Study Start

November 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

US(1)