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OpenTrials
Completed

NCT Number: NCT02658851

Cold Plasma for the Reduction of Lymphoceles Following PLND

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.

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Key information

Conditions

Lymphoceles Following Pelvic Lymph Node Dissection Cysts Hemic and Lymphatic Diseases Lymphatic Diseases Lymphocele Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Florida Hospital Global Robotics Institute

Celebration, Florida, 34747, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of Prostate Cancer (ICD-10:C61)
  • Prostate Specific Antigen (PSA) level =/> 10ng/mL
  • Gleason score =/> 7
  • Planned Elective Robotic Assisted Radical Prostatectomy with planned pelvic lymph node dissection.
  • Willing and able to return to clinic for standard of care abdominal ultrasound within 12 weeks post operatively.
  • Able to provide informed consent

Exclusion criteria

Must answer no to all:

  • Patient is unwilling or unable to sign or understand informed consent
  • Patient resides outside of the United States
  • Performance of Lymph node dissection was aborted.

Treatment and study plan

J-Plasma

Device

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

Other names: Cold plasma

Primary outcomes

  1. Number of Participants With Incidence of Lymphocele Formation

    Time frame: 12 weeks

    The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

Sponsors and collaborators

Lead sponsor

Apyx Medical

Industry

Collaborators

  • AdventHealth

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2016
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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