Cold Plasma for the Reduction of Lymphoceles Following PLND

Completed · Not applicable

Conditions studied: Lymphoceles Following Pelvic Lymph Node Dissection

In brief

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.

Key facts

Study ID

NCT02658851

Run by

Apyx Medical

People needed

100

Starts

2016-06-01

Expected to finish

2017-06-27

Last updated by the study team

2020-12-02

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Florida Hospital Global Robotics Institute — Celebration, Florida, United States

Full record on ClinicalTrials.gov

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