Prostate CancerNCT00792961
Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
A study testing Endomicroscopy in people with Prostate Cancer, run by Peter Delaney at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Endomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy
Who cannot join
- Patients under 18 years of age
- Patients with allergy or prior adverse reaction to Fluorescein Sodium
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hospital at Westlake Medical Center
Austin, Texas, 78746
About this study
Official title: In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study
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.
Read the 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
- Being tested
- Endomicroscopy
- Keywords
- Prostate cancer, Robotic surgery, Endomicroscopy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndomicroscopyDevice
Rigid drop-in endomicroscope imaging probe
| Study group | Role | What they receive |
|---|---|---|
| Endomicroscopy | Experimental | Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery Receives: Device: Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endomicroscopy images captured from prostate and surrounding tissues
Measured: During surgery
Secondary outcomes (1)
Comparison with conventional histology from corresponding biopsies or resection specimens
Measured: Post-surgery, after pathologist's review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Delaney
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital at Westlake
- Responsible party
- Sponsor-investigator, Peter Delaney, Optiscan Pty Ltd
- Investigators
- Randy Fagin, MD, Principal investigator, The Hospital at Westlake Medical CenterPeter Delaney, BSc, Study director, Optiscan Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792961
- Sponsor's protocol ID
- 13082008
- Status last verified
- Apr 2014
- First submitted
- 16 Nov 2008
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study
- ClinicalTrials.gov ID
- NCT00792961
- Acronym / sponsor ID
- 13082008
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Robotic surgery, Endomicroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Peter DelaneyIndustry (pharma, biotech, devices)
- Collaborators
- Hospital at Westlake
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endomicroscopy | Experimental | Device: EndomicroscopyEndomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Patients with allergy or prior adverse reaction to Fluorescein Sodium
- Patients unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndomicroscopyRigid drop-in endomicroscope imaging probe | Device | Endomicroscopy |
Primary outcome
Endomicroscopy images captured from prostate and surrounding tissues
Time frame: During surgery
1 secondary outcome
Comparison with conventional histology from corresponding biopsies or resection specimens
Time frame: Post-surgery, after pathologist's review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy Fagin, MD principal investigator
The Hospital at Westlake Medical Center
Peter Delaney, BSc study director
Optiscan Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endomicroscopy in people with Prostate Cancer, run by Peter Delaney at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endomicroscopy images captured from prostate and surrounding tissues (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.