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Cold Plasma for the Reduction of Lymphoceles Following PLND

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658851
Recruitment Status : Completed
First Posted : January 20, 2016
Results First Posted : December 2, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
AdventHealth
Information provided by (Responsible Party):
Apyx Medical

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoceles Following Pelvic Lymph Node Dissection Device: J-Plasma Not Applicable

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
Study Start Date : June 2016
Actual Primary Completion Date : June 27, 2017
Actual Study Completion Date : June 27, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: J-Plasma
Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.
 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.
Other Name: Cold plasma


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658851


Locations
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United States, Florida
Florida Hospital Global Robotics Institute
Celebration, Florida, United States, 34747
Sponsors and Collaborators
Apyx Medical
AdventHealth
Investigators
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Principal Investigator: Vipul R Patel, MD Florida Hospital Global Robotics Institute
  Study Documents (Full-Text)

Documents provided by Apyx Medical:
Study Protocol and Statistical Analysis Plan  [PDF] May 25, 2016

More Information
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Responsible Party: Apyx Medical
ClinicalTrials.gov Identifier: NCT02658851    
Other Study ID Numbers: 808076
First Posted: January 20, 2016    Key Record Dates
Results First Posted: December 2, 2020
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Apyx Medical:
lymphocele
pelvic lymph node dissection
robotic assisted radical prostatectomy
PLND
 RARP
prostatectomy
Patel
Additional relevant MeSH terms:
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Lymphocele
Cysts
Neoplasms
Lymphatic Diseases