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Pilot Study of VTI Doppler Probe Use to Identify Neurovascular Bundle During Prostate Surgery

NCT01794936 · Columbia University · Updated 29 May 2024

What is being tested
VTI Probe
For
Prostate Cancer; Nerve Sparing Prostatectomy
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 9 people. The full rules are on the registry page.
Where
United States
When
Starts or started Aug 2011, ends April 2012. Registered 20 Feb 2013.
Results
Posted on the registry on 22 April 2016.

In the researchers' words

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.
ClinicalTrials.gov, NCT01794936

Sites

  • Columbia University Medical CenterNew York, New York, United States