An interventional study of VTI Probe in Prostate Cancer and Nerve Sparing Prostatectomy, sponsored by Columbia University. Terminated at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Columbia University · Not applicable, Interventional, and Diagnostic
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.
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.
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This study's enrollment of 9 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
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.
Device: VTI Probe
Patients randomized to not receive probe evaluation.
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.
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.
Time frame: 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)
Time frame: During surgical procedure itself (~2-3 hours)
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.
| Milestone | VTI Probe or Non-Probe |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VTI Probe or Non-Probe | — | — | — |
| Age, Customized(participants) | VTI Probe or Non-Probe |
|---|---|
| 18 years and older | 9 |
| Sex: Female, Male(Participants) | VTI Probe or Non-Probe |
|---|---|
| Female | 0 |
| Male | 9 |
| Region of Enrollment(participants) | VTI Probe or Non-Probe |
|---|---|
| United States | 9 |
Plan to share: No
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