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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 16, 2008 | ||||||||
| Last Updated Date | November 18, 2008 | ||||||||
| Start Date ICMJE | November 2008 | ||||||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Endomicroscopy images captured from prostate and surrounding tissues [ Time Frame: During surgery ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00792961 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Comparison with conventional histology from corresponding biopsies or resection specimens [ Time Frame: Post-surgery, after pathologist's review ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery | ||||||||
| Official Title ICMJE | In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Open Label, Single Group Assignment | ||||||||
| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE | Device: Endomicroscopy | ||||||||
| Study Arms / Comparison Groups | Experimental: Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | August 2009 | ||||||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00792961 | ||||||||
| Responsible Party | Mr Peter Delaney, Optiscan | ||||||||
| Study ID Numbers ICMJE | 13082008 | ||||||||
| Study Sponsor ICMJE | Optiscan Pty Ltd | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Optiscan Pty Ltd | ||||||||
| Verification Date | November 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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