Cold Plasma for the Reduction of Lymphoceles Following PLND

Apyx Medical100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Lymphoceles Following Pelvic Lymph Node Dissection

Interventions

J-PlasmaDEVICE

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Primary diagnosis of Prostate Cancer (ICD-10:C61) 2. Prostate Specific Antigen (PSA) level =/\> 10ng/mL 3. Gleason score =/\> 7 4. Planned Elective Robotic Assisted Radical Prostatectomy with planned pelvic lymph node dissection. 5. Willing and able to return to clinic for standard of care abdominal ultrasound within 12 weeks post operatively. 6. Able to provide informed consent Exclusion Criteria: Must answer no to all: 1. Patient is unwilling or unable to sign or understand informed consent 2. Patient resides outside of the United States 3. Performance of Lymph node dissection was aborted.

Locations (1)

Florida Hospital Global Robotics Institute

Celebration, Florida, United States

Outcomes

Primary Outcomes

Number of Participants With Incidence of Lymphocele Formation

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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