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Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00792961
Enrollment
10
Registered
2008-11-18
Start date
2008-11-30
Completion date
2009-12-31
Last updated
2014-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Robotic surgery, Endomicroscopy

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.

Interventions

Rigid drop-in endomicroscope imaging probe

Sponsors

Hospital at Westlake
CollaboratorUNKNOWN
Peter Delaney
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Endomicroscopy images captured from prostate and surrounding tissuesDuring surgery

Secondary

MeasureTime frame
Comparison with conventional histology from corresponding biopsies or resection specimensPost-surgery, after pathologist's review

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026