Prostate CancerNCT01794936
Pilot Study of VTI Doppler Probe Use to Identify Neurovascular Bundle During Prostate Surgery
A study testing VTI Probe in people with Prostate Cancer and Nerve Sparing Prostatectomy, run by Columbia University at 1 site in United States.
Trial summary
This study is designed to evaluate the use of a disposable laparoscopic Doppler probe in robotic assisted prostatectomies. The Vascular Technology, Inc. (VTI) laparoscopic probe is simply a sterile, disposable Doppler probe that can be inserted through a laparoscopic trocar and placed on structures to determine if… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Nerve Sparing Prostatectomy
- What is being tested?
- VTI Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients must be 18 years of age or older and be able to read, understand and sign consent.
- Any patient undergoing robotic assisted laparoscopic prostatectomy (RALP)
- Any patient without moderate or severe erectile dysfunction (SHIM less than 15) undergoing bilateral or unilateral nerve-sparing RALP is eligible for this procedure.
Who cannot join
- Patients undergoing a non nerve-sparing RALP will be excluded from this study
- Those who receive a baseline SHIM score less than 15
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: VTI Doppler Probe For Robotic Surgery
This study is designed to evaluate the use of a disposable laparoscopic Doppler probe in robotic assisted prostatectomies. The Vascular Technology, Inc. (VTI) laparoscopic probe is simply a sterile, disposable Doppler probe that can be inserted through a laparoscopic trocar and placed on structures to determine if there is vascular flow demonstrating an audible pulse. During robotic-assisted prostatectomy, identification of vasculature is critical in order to prevent hemorrhage and effectively treat the underlying pathology. The investigators routinely utilize a combined Doppler ultrasound laparoscopic probe to identify vasculature during renal surgery, but Doppler ultrasound usage has not been adopted for prostatic surgery.
From a mechanical standpoint, these combination probes differ from the VTI probe in that they are approximately 2 times the diameter of the VTI probe, and the portion of the probe utilized for imaging much longer and on the side of the device. The VTI probe is much narrower, and the portion of the probe utilized for vessel identification is at the tip of the probe. For robotic-assisted prostatectomy, patients will be randomized to VTI laparoscopic Doppler System to identify pedicles and neurovascular bundles (NVB) or to robotic-assisted laparoscopic prostatectomy with no Doppler probe, which is the current standard of care.
Read the detailed description
The VTI Laparoscopic Doppler System is a blood flow detector that compensates for the loss of tactile sensation during laparoscopic procedures by helping the surgeon to identify vascular anatomy before it is visible to the eye. The system's sterile doppler probes fit through standard 5mm ports. It is simple to use and no special training is required. This study is designed to evaluate the use of the VTI (Nashua, NH) 20 megahertz (MHz) Microvascular Doppler probe in laparoscopic urological surgery.
Patients will take a preoperative sexual health inventory for men (SHIM) questionnaire. The investigators will then assess presence or absence of arterial and venous blood flow, in real-time during surgery. Additionally, the investigators will evaluate the safety of Doppler probe use, the surgical margin status on final pathology, and the post-operative erectile function of the patients with a followup SHIM questionnaire (to be performed 3 months after surgery). Finally, the robotic surgeon will document whether or not our original surgical plan was changed or remained the same after the Doppler use.
- Conditions
- Prostate Cancer, Nerve Sparing Prostatectomy
- Being tested
- VTI Probe
- Keywords
- Prostate cancer, Nerve Sparing Prostatectomy, VTI Probe
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTI ProbeDevice
The VTI 20 MHz microvascular Laparoscopic Doppler System is a blood flow detector that compensates for the loss of tactile sensation during laparoscopic procedures by eliminating misunderstandings related to surrounding vascular anatomy. The system's sterile doppler probes fit through standard 5mm ports, making it easy to use with no special training required.
| Study group | Role | What they receive |
|---|---|---|
| VTI Probe | Experimental | During robotic-assisted laparoscopic prostatectomy, the VTI Doppler probe (test) will utilized to measure blood blow within the neurovascular bundles. This is to be completed after the bladder neck and seminal vesicles are identified and dissected. To use the probe, the assistant surgeon will place the Doppler probe within the abdomen and systematically move it cephalad along the lateral prostate pedicles to identify NVB vessels. The Doppler flow in these regions will be quantified as arterial (strong) flow, venous (minimal) flow or no flow. The procedures will proceed by dissecting the lateral margin of prostate step by step up to the gland's apex. Blood loss and the time required to identify and dissect the NVB will be recorded. Receives: Device: VTI Probe |
| Non-Probe | No intervention | Patients randomized to not receive probe evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SHIM Score (Score of Erectile Function) Following Surgery
Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.
Measured: 8 months post-operative follow-up
Prevalence of Intra-operative Complications
Investigators will evaluate whether any intra-operative complications resulted from the use of the VTI probe to assess safety. Specifically, this time frame is limited from the induction of anesthesia through the completion of the surgical procedure (typically ~2-3 hours)
Measured: During surgical procedure itself (~2-3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketan Badani, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794936
- Sponsor's protocol ID
- AAAF3321
- Status last verified
- May 2024
- First submitted
- 9 Feb 2013
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VTI Doppler Probe For Robotic Surgery
- ClinicalTrials.gov ID
- NCT01794936
- Acronym / sponsor ID
- AAAF3321
- Conditions
- Prostate Cancer, Nerve Sparing Prostatectomy
- Keywords
- Prostate cancer, Nerve Sparing Prostatectomy, VTI Probe
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 22 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the use of a disposable laparoscopic Doppler probe in robotic assisted prostatectomies. The Vascular Technology, Inc. (VTI) laparoscopic probe is simply a sterile, disposable Doppler probe that can be inserted through a laparoscopic trocar and placed on structures to determine if there is vascular flow demonstrating an audible pulse. During robotic-assisted prostatectomy, identification of vasculature is critical in order to prevent hemorrhage and effectively treat the underlying pathology. The investigators routinely utilize a combined Doppler ultrasound laparoscopic probe to identify vasculature during renal surgery, but Doppler ultrasound usage has not been adopted for prostatic surgery.
From a mechanical standpoint, these combination probes differ from the VTI probe in that they are approximately 2 times the diameter of the VTI probe, and the portion of the probe utilized for imaging much longer and on the side of the device. The VTI probe is much narrower, and the portion of the probe utilized for vessel identification is at the tip of the probe. For robotic-assisted prostatectomy, patients will be randomized to VTI laparoscopic Doppler System to identify pedicles and neurovascular bundles (NVB) or to robotic-assisted laparoscopic prostatectomy with no Doppler probe, which is the current standard of care.
Detailed description
The VTI Laparoscopic Doppler System is a blood flow detector that compensates for the loss of tactile sensation during laparoscopic procedures by helping the surgeon to identify vascular anatomy before it is visible to the eye. The system's sterile doppler probes fit through standard 5mm ports. It is simple to use and no special training is required. This study is designed to evaluate the use of the VTI (Nashua, NH) 20 megahertz (MHz) Microvascular Doppler probe in laparoscopic urological surgery.
Patients will take a preoperative sexual health inventory for men (SHIM) questionnaire. The investigators will then assess presence or absence of arterial and venous blood flow, in real-time during surgery. Additionally, the investigators will evaluate the safety of Doppler probe use, the surgical margin status on final pathology, and the post-operative erectile function of the patients with a followup SHIM questionnaire (to be performed 3 months after surgery). Finally, the robotic surgeon will document whether or not our original surgical plan was changed or remained the same after the Doppler use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VTI Probe | Experimental | Device: VTI ProbeDuring robotic-assisted laparoscopic prostatectomy, the VTI Doppler probe (test) will utilized to measure blood blow within the neurovascular bundles. This is to be completed after the bladder neck and seminal vesicles are identified and dissected. To use the probe, the assistant surgeon will place the Doppler probe within the abdomen and systematically move it cephalad along the lateral prostate pedicles to identify NVB vessels. The Doppler flow in these regions will be quantified as arterial (strong) flow, venous (minimal) flow or no flow. The procedures will proceed by dissecting the lateral margin of prostate step by step up to the gland's apex. Blood loss and the time required to identify and dissect the NVB will be recorded. |
| Non-Probe | No intervention | –Patients randomized to not receive probe evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients must be 18 years of age or older and be able to read, understand and sign consent.
- Any patient undergoing robotic assisted laparoscopic prostatectomy (RALP)
- Any patient without moderate or severe erectile dysfunction (SHIM less than 15) undergoing bilateral or unilateral nerve-sparing RALP is eligible for this procedure.
Key exclusion criteria (2 listed)
- Patients undergoing a non nerve-sparing RALP will be excluded from this study
- Those who receive a baseline SHIM score less than 15
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 |
|---|---|---|
| VTI ProbeThe VTI 20 MHz microvascular Laparoscopic Doppler System is a blood flow detector that compensates for the loss of tactile sensation during laparoscopic procedures by eliminating misunderstandings related to surrounding vascular anatomy. The system's sterile doppler probes fit through standard 5mm ports, making it easy to use with no special training required. | Device | VTI Probe |
Primary outcome
Change in SHIM Score (Score of Erectile Function) Following Surgery
Time frame: 8 months post-operative follow-up
Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.
Prevalence of Intra-operative Complications
Time frame: During surgical procedure itself (~2-3 hours)
Investigators will evaluate whether any intra-operative complications resulted from the use of the VTI probe to assess safety. Specifically, this time frame is limited from the induction of anesthesia through the completion of the surgical procedure (typically ~2-3 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ketan Badani, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VTI Probe in people with Prostate Cancer and Nerve Sparing Prostatectomy, run by Columbia University 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 May 2024. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in SHIM Score (Score of Erectile Function) Following Surgery (time frame: 8 months post-operative follow-up). The study lists 2 primary outcomes in all. 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 29 May 2024.