VTI Doppler Probe For Robotic Surgery
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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.
8 months post-operative follow-up
Ketan Badani, MD
United States: Food and Drug Administration
|Columbia University Medical Center||New York, New York 10032|