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Cold Plasma for the Reduction of Lymphoceles Following PLND

NCT02658851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-12-02

Study results available
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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.

Conditions

  • Lymphoceles Following Pelvic Lymph Node Dissection

Interventions

DEVICE

J-Plasma

Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

Sponsors & Collaborators

  • AdventHealth

    collaborator OTHER

  • Apyx Medical

    lead INDUSTRY

Principal Investigators

  • Vipul R Patel, MD · Florida Hospital Global Robotics Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-27
Completion
2017-06-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02658851 on ClinicalTrials.gov