Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
Phase: NA
Conditions: Lymphoceles Following Pelvic Lymph Node Dissection
Sponsor: Apyx Medical

 
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Study Protocol Title: 
Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic 
LymphNode Dissection During Robot-Assisted Radical Prostatectomy 
 
Study Sponsor:   
Bovie Medical Corporation 
5115 Ulmerton Road 
Clearwater, FL  33760-4004 USA 
Phone:  (800)537-2790 
Fax:  (800)323-1640 
 
Principal Investigator: 
Dr. Vipul Patel 
Global Robotics Institute 
Florida Hospital Celebration Health 
410 Celebration Place, Suite 300 
Celebration, FL  34747 
(407)303-4673 
 
 

 
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Table of Contents: 
List of Abbreviations: ..................................................................................................................... 4 
Introduction ..................................................................................................................................... 5 
Background Information and Scientific Rationale ......................................................................... 5 
Study Objectives ............................................................................................................................. 6 
Primary Objective/Aim/Goal/Hypothesis ................................................................................... 6 
Secondary Objective/Aim/Goal/Hypothesis ............................................................................... 6 
Study Design ................................................................................................................................... 6 
Research Design.......................................................................................................................... 6 
Study Agent, Device, and/or Intervention Description ............................................................... 6 
Study Site(s)/Location(s) and Number of Subjects .................................................................... 7 
Multi-Site Research Logistics/Communication Plan .................................................................. 7 
Research Conducted in a Foreign Country ................................................................................. 7 
Community-Based Participatory Research ................................................................................. 7 
Subject Selection ............................................................................................................................. 7 
Vulnerable Populations (if applicable) ....................................................................................... 7 
Inclusion Criteria ........................................................................................................................ 7 
Exclusion Criteria ....................................................................................................................... 7 
Resources Available........................................................................................................................ 8 
Study Procedures ............................................................................................................................ 8 
Subject Recruitment and Screening ............................................................................................ 8 
Consent Process and Documentation .......................................................................................... 8 
Waiver of Written Documentation of Consent or Waiver of Consent ........................................ 8 
Documentation of Informed Consent Process ............................................................................ 9 
Randomization ............................................................................................................................ 9 
Study Visits ................................................................................................................................. 9 
Study Duration .......................................................................................................................... 10 
Materials of Human Origin:  Collection, Preparation, Handling and Shipping........................ 10 
Study Outcome Measures (Endpoints) ......................................................................................... 10 
Data Management and Quality Plan ............................................................................................. 11 
Data De-identification ............................................................................................................... 11 
Data Confidentiality, Storage, and Retention ........................................................................... 11 
Data Quality .............................................................................................................................. 11 
Data Sharing (outside of Florida Hospital) ............................................................................... 11 

 
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Sample Size Determination........................................................................................................... 12 
Statistical Analysis Plan ................................................................................................................ 12 
Primary Objective Analysis ...................................................................................................... 12 
Potential Risks and Benefits ......................................................................................................... 12 
Potential Benefits ...................................................................................................................... 12 
Potential Risks .......................................................................................................................... 12 
Mitigation of Risks ................................................................................................................... 13 
Provisions to Protect the Privacy Interest of Subjects .............................................................. 13 
Early Withdrawal of Subjects ....................................................................................................... 13 
Investigator Withdrawal of Subjects ......................................................................................... 13 
Subject Request for Withdrawal from Study ............................................................................ 13 
Data Collection and Follow-up for Withdrawn Subjects .......................................................... 13 
Adverse Event Reporting: ............................................................................................................. 14 
Adverse Events ......................................................................................................................... 14 
Recording and Notification of Adverse Events ........................................................................ 14 
Safety Monitoring Plan ................................................................................................................. 15 
Data and Safety Monitoring Board (DSMB) or Equivalent ..................................................... 15 
Ethical Considerations .................................................................................................................. 15 
Sharing of Results with Subjects .............................................................................................. 15 
Funding Source ............................................................................................................................. 15 
Subject Stipends or Payments ....................................................................................................... 15 
Publication Plan ............................................................................................................................ 15 
References ..................................................................................................................................... 16 

 
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List of Abbreviations: 
PCa 
 
Prostate Cancer 
 
CH 
 
Celebration Health 
 
ESU 
 
Electrosurgical Generator Unit 
 
FDA  
Food and Drug Administration 
 
FH 
 
Florida Hospital 
 
IFU 
 
Instructions for Use 
 
PI 
 
Principal Investigator 
 
PLND  
Pelvic Lymph Node Dissection 
 
RARP  
Robot-Assisted Radical Prostatectomy 
 
RF 
 
Radiofrequency 
 
USA  
United States of America 
 
 

 
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Introduction 
This document is a protocol for a human research study. This study is to be conducted according 
to United States standards of Good Clinical Practice in accordance with applicable Federal 
regulations and institutional research policies and procedures.  
 
Prostate cancer (PCa) is the third most common cause of cancer related death in the United 
States and is the most prevalent non-cutaneous cancer [1].  Pelvic lymph node dissection 
(PLND) following robot-assisted radical prostatectomy (RARP) is an established technique for 
determining lymph node metastases [2].  The most frequent post-operative complication of 
PLND is lymphocele formation. Lymphoceles occur as a result of lymph leakage from lymphatic 
channels that have been cut during dissection. The Principal Investigator (PI) has previously 
published findings of an occurrence rate of 51% for lymphocele formation with 15.4% from 
them being clinically symptomatic. The overall frequency of symptomatic lympocele in patient’s 
that underwent bilateral PLND was equal 6.6% of the evaluated group in this publication [3].  
 We hypothesize that the incidence of lymphocele’s should decrease significantly by attending to 
careful sealing of these channels using adequate hemostatic tools [3].  
 
 
Background Information and Scientific Rationale 
 
Bovie Medical Corporation’s J-Plasma® helium based plasma technology is a hemostatic tool 
with FDA clearance for the cutting, coagulation, and ablation of soft tissue.  The J-Plasma® 
system consists of an electrosurgical generator unit (ESU), a handpiece, and a supply of helium 
gas.  Radiofrequency (RF) energy is delivered to the handpiece by the ESU and used to energize 
an electrode.  When helium gas is passed over the energized electrode, a helium plasma is 
generated which allows for conduction of the RF energy from the electrode to the patient in the 
form of a precise helium plasma beam.  The energy delivered to the patient via the helium 
plasma beam is very precise and cooler in temperature in comparison to other surgical energy 
modalities such as standard RF monopolar energy.  Previous studies comparing J-Plasma® to 
other energy sources demonstrated less or comparable lateral and depth of thermal spread for J-
Plasma® in porcine peritoneum, bladder, and small intestine [4].  The precise delivery of energy 
and minimal thermal injury to collateral tissue makes J-Plasma® a useful surgical tool in 
procedures such as radical prostatectomy where minimizing damage to collateral tissue is crucial 
to preserving sexual function and continence.  As an example, J-Plasma® has been shown to be 
clinically effective in the treatment of endometriosis on fallopian tubes, ovaries, and other 
delicate structures where current RF energy sources cannot be used due to risk of damage [5,6]. 
 
This study protocol will evaluate the efficacy of the J-Plasma® helium based plasma technology 
in the reduction of lymphoceles following PLND during 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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Study Objectives 
The primary objective of this study is to evaluate the efficacy of the J-Plasma® helium based 
plasma technology in the reduction of lymphoceles following PLND during RARP. 
 
PRIMARY OBJECTIVE/AIM/GOAL/HYPOTHESIS 
J-Plasma® helium based plasma technology will reduce the occurrence of lymphoceles 
when used to perform PLND during RARP. 
 
SECONDARY OBJECTIVE/AIM/GOAL/HYPOTHESIS 
N/A 
 
 
Study Design 
RESEARCH DESIGN 
The study will be a single institution, single arm prospective trial where by 100 patients 
will be enrolled.   
Participants evaluated and scheduled for a PLND during Robotic Assisted Radical 
Prostatectomy by Dr. Vipul Patel 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 as this is the standard of 
care within Dr. Vipul Patel’s clinical practice for all patients who undergo a PLND 
during RARP.  The occurrence rate of lymphoceles in this trial group of 100 patients will 
be compared to retrospective data of 100 patients acquired from the IRB approved 
Urologic Robotic Surgery Outcomes Registry # 237998 using the same inclusion/exclusion 
criteria as defined for enrollment in this protocol   and from other published data to 
determine if the occurrence rate has been reduced.   
 
 
STUDY AGENT, DEVICE, AND/OR INTERVENTION DESCRIPTION  
 
The study will be conducted using components of the Bovie Medical J-Plasma® 
system that have received FDA clearance and are currently commercially 
available.  The J-Plasma® handpieces were cleared under FDA 510k numbers 
K112233 and K151325 for the delivery of helium gas plasma for cutting, 
coagulation, and ablation of soft tissue.  The Bovie Ultimate high frequency 
electrosurgical generator was cleared under FDA 510k number K142975 for 
delivery of RF energy and/or helium gas plasma to cut, coagulate, and ablate soft 
tissue.  Therefore, the cutting, coagulation, and ablation of soft tissue during 
PLND would be considered on label for the study devices. 
 
 
 

 
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STUDY SITE(S)/LOCATION(S) AND NUMBER OF SUBJECTS 
 
Florida Hospital Celebration Global Robotics Institute: 
Estimated number of subjects at Florida Hospital sites: 100 
 
Total number of all sites: 1 
Estimated number of subjects at all sites combined: 100 
 
MULTI-SITE RESEARCH LOGISTICS/COMMUNICATION PLAN 
N/A 
RESEARCH CONDUCTED IN A FOREIGN COUNTRY 
N/A 
 
COMMUNITY-BASED PARTICIPATORY RESEARCH 
N/A 
 
Subject Selection 
VULNERABLE POPULATIONS (IF APPLICABLE) 
  
N/A 
Employees:  If an FH employee meets inclusion criteria their non-participation will not 
affect their employment status. 
 
INCLUSION CRITERIA 
 
 Must answer yes to all: 
1. Age 18 – 80 
2. Primary diagnosis of Prostate Cancer (ICD-10:C61) 
3. Prostate Specific Antigen (PSA) level > 10ng/mL and/or 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. 
      4. Presence of implanted mechanical cardiac device. 
 

 
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Resources Available 
 
The research team assigned to the study for screening, consenting and data collection 
purposes will the Research Coordinator who is a RN and three data abstractors that work 
on post-operative RARP patient follow up. Two members are medical assistants with 
experience of screening and consenting in research as well as clinical experience in 
urology.  
• Justify the feasibility of recruiting the required number of suitable subjects 
within the agreed recruitment period. Dr. Patel’s clinical practice sees 
approximately 900 patients a year in consultation for RARP as treatment 
for prostate cancer. Approximately 11% will be needed for enrollment. 
• There is no additional surgical time needed for this study.  The 
approximate surgical time is 90 minutes.  
 
Study Procedures 
 
SUBJECT RECRUITMENT AND SCREENING 
 
Participants for enrollment will be recruited from the clinical practice of Dr. Vipul Patel.  
A researcher will screen the patient’s medical record specifically looking at diagnostic 
lab and path reports to verify inclusion/exclusion criteria for potential enrollment. 
If the patient indicates he would like more information, a qualified researcher will 
approach the patient, in a private room, to provide an overview of the study.  
 
 
CONSENT PROCESS AND DOCUMENTATION 
      If the patient meets the criteria for enrollment and is interested in 
participating in the study, a researcher will be notified and the informed 
consent process will commence. Patients will be informed that their 
participation in the study is voluntary and the decision to participate in no 
way will affect their care for prostate cancer.  If the patient continues to 
express interest in the study, a copy of the IRB approved informed consent 
form will be given to the patient to read.  The patient will be able to ask 
questions and have a sufficient amount of time prior to signing the informed 
consent document. After signing the informed consent form, a complete and 
signed copy will be given provided to the patient. 
      In the unlikely event that a non-English speaking patient meets criteria for 
enrollment, then IRB Short Form procedures will be initiated. 
Waiver of Written Documentation of Consent or Waiver of Consent We are 
requesting a HIPAA waiver for the de-identifiied comparison group that will be looked at 

 
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to compare findings of lymphocele formation.  This group whose data already exists will 
be extracted from our urological outcomes database identified in IRBnet as #237998 
which has a waiver of consent in place for data used in research. 
N/A 
Subjects who are not yet adults (infants, children, teenagers) 
N/A 
Cognitively Impaired Adults 
• During screening the health and physical is examined for inclusion and 
exclusion criteria including information about their past medical and social 
history.  Information from the patient record as well as verbal questioning 
will be used to identify possible impairment.   
Adults Unable to Consent 
                          N/A- informed consent by the patient is a requirement for inclusion. 
DOCUMENTATION OF INFORMED CONSENT PROCESS 
 
Documentation of the informed consent process is required to establish that the subject 
was accurately and adequately informed and that no study-related procedures were 
initiated prior to obtaining informed consent.  A research team member will note in the 
source documentation the consent process, date consent was obtained and that consent 
was obtained prior to initiating any research procedures. 
 
 
RANDOMIZATION 
N/A 
 
 
 
STUDY VISITS  
 
Visit 1: Inclusion and exclusion criteria will be reviewed.  If the patient meets criteria, he 
will be invited to participate in the research study.  The patient will be given the informed 
consent and it will be reviewed with the patient and all questions will be answered.  
 
 
Visit 2: Day of Surgery. The only non-standard of care item will be with the use of The 
Bovie J plasma at lymph node dissection and will not be billed to patient. 
 
Visit 3: Patient returns to Dr. Patel’s clinical practice for routine standard of care exam 
and abdominal ultrasound done at Florida Hospital Celebration.  
 
The following table identifies the procedures in relation to the study timeline.  

 
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STUDY VISIT 
SCHEDULE 
Visit 1 
Screening/Consent 
Visit 2   
Surgery day 
 Visit 3  
Abdominal US 
8wks post op 
    +/- 4 weeks 
 
Inclusion and 
Exclusion Criteria 
X 
 
 
 
Informed Consent 
X 
 
 
 
RARP with PLND 
 
X 
 
 
Abdominal US 
 
 
X 
 
  
 
 
STUDY DURATION 
The study is projected to begin February 2016 once ORA and IRB approval are awarded. 
 
The estimated duration to enroll all study subjects is one year from study approval date.  
 
Participants will remain in the study for 4 months following their robotic assisted radical 
prostatectomy with pelvic lymph node dissection. 
 
The estimated date for investigators to complete the study and analysis of data July 2017. 
 
MATERIALS OF HUMAN ORIGIN:  COLLECTION, PREPARATION, HANDLING AND SHIPPING 
N/A    
 
Study Outcome Measures (Endpoints) 
The primary outcome to be measured will be the incidence of lymphocele formation as 
diagnosed upon post- operative abdominal ultrasound.  The incidence of lymphocele formation 
in patients undergoing pelvic lymphnode dissection using the JPlasma® will be compared to de-
identified retrospective data of lymphocele formation without the use of JPlasma® extracted 
from Dr. Patel’s urologic outcomes registry identified by IRBnet #237998.   
 
 
The following data variables and materials will be collected for analysis in this study: 
• Age at day of surgery 
• Pre-operative Gleason Score 
• Pre-operative PSA lab value 
• Clinical variables: pathology report from RARP, radiology report from abdominal 
ultrasound, physician notes, nurses notes. 
 
 

 
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Data Management and Quality Plan 
DATA DE-IDENTIFICATION 
 
• Unique identifiers will be generated by the researcher at the time of enrollment.  The 
number will consist of the last two digits of the year enrolled as well as the number to 
designate the order in which enrollment occurred.  
Ex: first patient enrolled during 2016 would be designated as patient 16-01 
•  Data is linked by the research coordinator creating a master log containing patient 
Name, DOB, DOS MRN and study ID number. 
• This link will be used for auditing purposes. 
• The linked study master file will be kept on the FH H: drive in a password protected 
file. 
• Members of the GRI Study team as listed on the Delegation Log will have access to 
this linked file. 
• Data will be stored for a minimum of 7 years after the closure of the study. 
• The link will be kept for a minimum of 7 years after study closure. 
 
 
DATA CONFIDENTIALITY, STORAGE, AND RETENTION 
 
All electronic data will be stored in the FH H: drive.  Only FH employees will have 
access to this drive.  All files with identifiable data will be encrypted with password 
protection.  Only those indicated on the Delegation Log will have access to the data.  The 
study documentation and paperwork will be stored at Florida Hospital Global Robotics 
Institute in a locked storage closet during the course of the study. After study closure data 
will be retained for 7 years at Iron Mountain Records Facility. After that period of time, 
all individual patient study information will be shredded. 
 
 
DATA QUALITY  
 
Quality control procedures for this research study include source data verification by 
randomly selecting 10% of subject records with comparison between the paper case 
report form (CRF) and the medical record and/or electronic database record of those 
same data.  If errors are common, data will be completely checked prior to data analysis.   
 
 
DATA SHARING (OUTSIDE OF FLORIDA HOSPITAL)  
If any data is to be shared outside of Florida Hospital a formal request will be made to the 
ORA and FH legal. 
 
  

 
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Sample Size Determination 
 
 The primary outcome measure is the incidence of lymphocele after robot assisted pelvic lymph 
node dissection. A previously published paper by Dr. Patel on this topic using a cohort of 76 
patients was referred to for sample size determination [3].    
 
Statistical Analysis Plan 
 
PRIMARY OBJECTIVE ANALYSIS 
The primary variable of interest is the incidence of lymphocele formation measured at 
approximately 8 weeks post-operatively.  The incidence of lymphocele formation will be 
compared between the 100 enrolled “treatment” group and a propensity matched “non-
treatment” group that will be established using equal inclusion/exclusion criteria, this 
retrospective lymphocele data will be retrieved from the Urologic Robotic Surgery Outcomes 
Registry identified by IRBnet #237998.  Additional comparisons of demographic (age, 
race/ethnicity) and oncological information will be accessed to ensure no differences 
between the two groups.   
 
 
Potential Risks and Benefits 
POTENTIAL BENEFITS 
Lymphocele’s can lead to symptoms and secondary complications such as abdominal 
pain, leg pain, lower limb edema, constipation, urinary frequency, deep vein thrombosis 
and infection or sepsis. 
The potential benefits of enrollment of this study will be a hypothesized reduction in the 
incidence of lymphocele formation thus resulting in a decrease of the symptoms 
associated with such formation.   
 
POTENTIAL RISKS 
 
Risks associated with robotic radical prostatectomy as discussed and stated by the 
physician and included in the surgery consent signed by the patient regardless of 
enrollment in this study include: severe loss of blood, damage to surrounding organs, 
tissues, vessels, infection / any of which may necessitate a return to surgery, cardiac 
arrest which may result from the performance of any surgery/ procedure(s), and in some 
cases, may lead to partial or permanent disability or death.  Additional risks may include, 
but are not limited to: urinary incontinence, erectile dysfunction, rectal/bowel/ureter 
injury, bladder neck contracture, pulmonary embolism, urine leak, pneumonia, problems 
related to positioning and endotracheal tube, blood transfusion, embolus from pneumo-
peritoneum, unrecognized injuries and lymphocele formation. 
 
JPlasma® has minimal lateral and depth of thermal spread in a variety of tissue types 
however; possible risks associated with JPlasma® are: unintended surgical site burns due 
to direct contact with the cutting tip electrode.  Inadvertent activation or movement of the 
cutting tip instrument outside the field of vision may result in injury to the patient or 

 
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surgical team. Electrosurgical devices may cause interference with pacemakers or other 
implants. 
 
MITIGATION OF RISKS  
Side effects will be monitored during follow-up study visits.   
 
PROVISIONS TO PROTECT THE PRIVACY INTEREST OF SUBJECTS 
Subjects will be assigned unique identifiers for study-related records.   All precautions 
will be taken to make sure that only authorized individuals will access subject research 
records.  Each member of the Florida Hospital Celebration GRI research team will have 
access to the securely stored medical charts within Dr. Patel’s practice, also the team has 
a unique id and password allowing them access to electronic medical records. All 
research team members are trained to follow Florida Hospital’s policy on the protection 
of patient’s health and private information.  The collection of sensitive information about 
subjects will be limited to minimum necessary to achieve the aims of the research, so that 
no unneeded sensitive information will be collected.  
 
 
Early Withdrawal of Subjects 
INVESTIGATOR WITHDRAWAL OF SUBJECTS 
Patients that did not receive a pelvic lymph node dissection at the discretion of the 
surgeon during their robotic radical prostatectomy will be withdrawn from the study.   
 
Patients that do not return for the abdominal ultrasound post operatively as ordered by the 
physician will be withdrawn from the study. 
 
If a patient is withdrawn from the study they will be notified via telephone call by GRI 
Research Staff. After 3 failed attempts by phone a certified letter will be mailed to the 
patient as the final attempt of notification.  
  
All withdrawn participants will be documented in the regulatory binder. 
 
SUBJECT REQUEST FOR WITHDRAWAL FROM STUDY 
 
Subjects may voluntarily withdraw consent at any time during the study without penalty. 
In all cases of withdrawal, the date and the reason for withdrawal are to be documented 
per site standard operating procedure.   
 
DATA COLLECTION AND FOLLOW-UP FOR WITHDRAWN SUBJECTS 
 
Patients who request withdrawal prior to the post-operative abdominal ultrasound will not 
be included in the final analysis as there would be unsuccessful collection of the data 
necessary to conclude the study’s end point.  Patients who request to withdraw after the 
abdominal ultrasound will have their data maintained in the research database up to the 

 
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point of withdrawal.  This data will be included in subsequent analysis because keeping 
these patients in the analysis is essential for study validity. 
 
Adverse Event Reporting: 
ADVERSE EVENTS 
 
An adverse event (AE) is any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign (for example, abnormal physical exam or laboratory finding), 
symptom, or disease temporally associated with the subject’s participation in the research, 
whether or not considered related to the subject’s participation in the research.  
 
Adverse events will be documented as anticipated or unanticipated; minor or serious; 
and, related or unrelated to study intervention.  
 
Serious Adverse Event (SAE): A Serious Adverse Event is defined as an AE meeting 
one of the following outcomes: 
• Death during the period of protocol defined surveillance 
• Life Threatening Event (defined as a participant at immediate risk of death at the 
time of the event) 
• Inpatient hospitalization or prolongation of existing hospitalization during the 
period of protocol defined surveillance  
• Results in a persistent or significant disability/incapacity 
 
All adverse events that do not meet any of the criteria for “serious” should be regarded 
as minor adverse events.  
 
A preexisting condition is one that is present at the start of the study.  A preexisting 
condition will be recorded as an adverse event only if the frequency, intensity, or the 
character of the condition worsens during the study period. 
 
Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported 
as an adverse event in the following circumstances: 
• Hospitalization or prolonged hospitalization for diagnostic or elective surgical 
procedures for a preexisting condition. Surgery should not be reported as an 
outcome of an adverse event if the purpose of the surgery was elective or diagnostic 
and the outcome was uneventful. 
• Hospitalization or prolonged hospitalization for therapy of the target disease of the 
study, unless it is a worsening or increase in frequency of hospital admissions as 
judged by the clinical investigator. 
 
RECORDING AND NOTIFICATION OF ADVERSE EVENTS 
 
At each contact with the subject, the investigator will seek information on adverse events 
by specific questioning and, as appropriate, by examination.  Information on all adverse 

 
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events will be recorded immediately in the source document, and also in the appropriate 
adverse event module of the case report form (CRF).  All clearly related signs, 
symptoms, and abnormal diagnostic procedures results will be recorded in the source 
document. 
            All adverse events will be reported according to Florida Hospital IRB guidelines. 
 
 
Safety Monitoring Plan   
 Research and safety data will be reviewed by the PI. This review will take place at regular 
meetings  for every 25 enrolled subjects or every 4 months from the first date of enrollment 
which ever should occur first.  These meetings will be with the research coordinator.  All CRF 
data will be source data verified using a risk-based approach to assure the accuracy of the 
reported data.  
DATA AND SAFETY MONITORING BOARD (DSMB) OR EQUIVALENT 
 
N/A 
 
Ethical Considerations 
N/A 
 
SHARING OF RESULTS WITH SUBJECTS 
The ordering physician and or his staff will inform the patient of all results of 
their surgery.  It is standard practice to review the peri-operative and post-
operative findings with the patient during their post-operative clinic examination. 
 
Funding Source 
This study will be supported by funding from Bovie Medical Corporation.  
 
Subject Stipends or Payments 
N/A 
 
Publication Plan 
 
Publication of the results will be based upon appropriate analysis and review of the complete 
data, and the rules of The International Committee of Medical Journal Editors (ICMJE) for 
determining authorship will be followed and will guide scientific presentation and publication of 
the results of this study.  Florida Hospital shall be entitled to use the trial results for its own 
internal teaching, research, education, clinical and publication purposes without the payment of 
royalties or other fees.  
 
 
 
 
 
 

 
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References 
1. Walsh PC, Partin AW, Epstein JI.  Cancer control and quality of life following anatomical 
radical retropubic prostatectomy: results at 10 years.  J. Urol.  1994; 152:1831-6. 
2. Zorn KC, Katz MH, Berstein A, et al.  Pelvic lymphadectomy during robot-assisted radical 
prostatectomy:  assessing nodal yield, perioperative outcomes, and complications.  
Urology.  2009; 74:296-302.  
3. Orvieto MA, Coelho RF, Chauhan S, et al.  Incidence of lymphoceles after robot-assisted 
pelvic lymph node dissection.  BJUI.  2011;108:1185-1190. 
4. Pedroso J, Gutierrez M, Volker W. J-Plasma, monopolar pencil, argon beam and CO2 laser 
electrosurgery: comparative evaluation of thermal spread in a porcine tissue model (White 
Paper). Bovie Medical Corporation. June 2014.  
5. McCoy CE.  Novel Surgical Approach Targeting Chronic Pelvic Pain with Plasma® 
(White Paper).  Bovie Medical Corporation.   
6. McCoy CE.  Treating Endometriosis and Chronic Pelvic Pain with J-Plasma® (White 
Paper).  Bovie Medical Corporation.