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| Sponsor: | Optiscan Pty Ltd |
|---|---|
| Information provided by: | Optiscan Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT00792961 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Device: Endomicroscopy |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Endomicroscopy
Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery
|
Device: Endomicroscopy
Rigid drop-in endomicroscope imaging probe
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Randy Fagin, MD | 512-657-6548 | randy.fagin@gmail.com |
| United States, Texas | |
| The Hospital at Westlake Medical Center | Recruiting |
| Austin, Texas, United States, 78746 | |
| Contact: Randy Fagin, MD 512-657-6548 | |
| Principal Investigator: Randy Fagin, MD | |
| Principal Investigator: | Randy Fagin, MD | The Hospital at Westlake Medical Center |
| Study Director: | Peter Delaney, BSc | Optiscan Pty Ltd |
More Information
| Responsible Party: | Mr Peter Delaney, Optiscan |
| ClinicalTrials.gov Identifier: | NCT00792961 History of Changes |
| Other Study ID Numbers: | 13082008 |
| Study First Received: | November 16, 2008 |
| Last Updated: | November 18, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Prostate cancer Robotic surgery Endomicroscopy |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |