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Prevention of Lymphoceles After Robotic PLND

NCT02035475 · OhioHealth · Updated 15 Nov 2016

What is being tested
Intuitive Vessel Sealer
For
Lymphoceles; Prostate Cancer
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 120 people. The full rules are on the registry page.
Where
United States
When
Starts or started Aug 2014, ends Dec 2014. Registered 14 Jan 2014.
Results
Posted on the registry on 15 Nov 2016.

In the researchers' words

The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. Their use in this study will be to perform tissue transection during PLND such that the intended use is within the FDA-approved domain for this instrument. Investigators intend to identify whether its use for PLND reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during PLND. Because the instrument is new and has been FDA approved for less than one year, there is no published literature regarding its use to date. Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. Investigators propose a total sample size of 120 patients.
ClinicalTrials.gov, NCT02035475

Sites

  • Dublin Methodist HospitalColumbus, Ohio, United States