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Cold Plasma for the Reduction of Lymphoceles Following PLND

Primary Purpose

Lymphoceles Following Pelvic Lymph Node Dissection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
J-Plasma
Sponsored by
Apyx Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphoceles Following Pelvic Lymph Node Dissection focused on measuring lymphocele, pelvic lymph node dissection, robotic assisted radical prostatectomy, PLND, RARP, prostatectomy, Patel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Hospital Global Robotics Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

J-Plasma

Arm Description

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2016
Last Updated
December 1, 2020
Sponsor
Apyx Medical
Collaborators
AdventHealth
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1. Study Identification

Unique Protocol Identification Number
NCT02658851
Brief Title
Cold Plasma for the Reduction of Lymphoceles Following PLND
Official Title
Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 27, 2017 (Actual)
Study Completion Date
June 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apyx Medical
Collaborators
AdventHealth

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoceles Following Pelvic Lymph Node Dissection
Keywords
lymphocele, pelvic lymph node dissection, robotic assisted radical prostatectomy, PLND, RARP, prostatectomy, Patel

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
J-Plasma
Arm Type
Experimental
Arm Description
Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.
Intervention Type
Device
Intervention Name(s)
J-Plasma
Other Intervention Name(s)
Cold plasma
Intervention Description
Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.
Primary Outcome Measure Information:
Title
Number of Participants With Incidence of Lymphocele Formation
Description
The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vipul R Patel, MD
Organizational Affiliation
Florida Hospital Global Robotics Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital Global Robotics Institute
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cold Plasma for the Reduction of Lymphoceles Following PLND

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