Cold Plasma for the Reduction of Lymphoceles Following PLND

Not Applicable

Completed

• Conditions: Lymphoceles Following Pelvic Lymph Node Dissection
• Interventions: Device: J-Plasma

• Registration Number: NCT02658851
• Lead Sponsor: Apyx Medical

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.

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-20
• Study Start: 2016-06
• Primary Completion: 2017-06-27
• Study Completion: 2017-06-27
• Results First Submitted: 2020-01-23
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Results First Posted: 2020-12-02
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Incidence of Lymphocele Formation	12 weeks	The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

Trial Locations

Locations (1)

Florida Hospital Global Robotics Institute; 🇺🇸 Celebration, Florida, United States