Cold Plasma for the Reduction of Lymphoceles Following PLND

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Lymphoceles Following Pelvic Lymph Node Dissection

Intervention / Treatment
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* Device: J-Plasma


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: J-Plasma<br>Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. | Device: J-Plasma<br>* Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.<br>* Other names: Cold plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphocele, pelvic lymph node dissection, robotic assisted radical prostatectomy, PLND, RARP, prostatectomy, Patel