Cold Plasma for the Reduction of Lymphoceles Following PLND

NCT02658851 | Completed Results FDA Device

• 1 other identifier: 808076
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoceles Following Pelvic Lymph Node Dissection

Keywords

lymphocele; pelvic lymph node dissection; robotic assisted radical prostatectomy; PLND; RARP; prostatectomy; Patel

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (1)

J-Plasma

EXPERIMENTAL

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

Device: J-Plasma

Interventions

J-Plasma DEVICE

Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

Also known as: Cold plasma

J-Plasma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Apyx Medical: lead
• AdventHealth: collaborator

Study Sites (1)

Florida Hospital Global Robotics Institute

Celebration, Florida, 34747, United States

Location

MeSH Terms

Conditions

Lymphocele

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Kari Larson
• Organization: Apyx Medical

kari.larson@apyxmedical.com

8012440058

Study Officials

• Vipul R Patel, MD

  Florida Hospital Global Robotics Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)