Clinical Trial: Cold Plasma for the Reduction of Lymphoceles Following PLND

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy

Brief Summary: This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.

Detailed Summary: Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.
Sponsor: Bovie Medical Corporation

Current Primary Outcome: Incidence of lymphocele formation [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bovie Medical Corporation

Dates:
Date Received: January 15, 2016
Date Started: June 2016
Date Completion: July 2017
Last Updated: December 1, 2016
Last Verified: December 2016