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VTI Doppler Probe For Robotic Surgery

18 Years
Not Enrolling
Prostate Cancer, Nerve Sparing Prostatectomy

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Trial Information

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients undergoing a non nerve-sparing RALP will be excluded from this study

- Those who receive a baseline SHIM score less than 15

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Change in SHIM Score (score of erectile function) following surgery

Outcome Description:

Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.

Outcome Time Frame:

8 months post-operative follow-up

Safety Issue:


Principal Investigator

Ketan Badani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

April 2012

Related Keywords:

  • Prostate Cancer
  • Nerve Sparing Prostatectomy
  • Prostate cancer
  • Nerve Sparing Prostatectomy
  • VTI Probe
  • Prostatic Neoplasms



Columbia University Medical Center New York, New York  10032