Cold Plasma for the Reduction of Lymphoceles Following PLND

Lymphoceles Following Pelvic Lymph Node Dissection Clinical Trial

Official title:

Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658851
• Other study ID #: 808076
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 27, 2017

Study information

• Verified date: December 2020
• Source: Apyx Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphocele
• Lymphoceles Following Pelvic Lymph Node Dissection

Intervention

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.

Locations

Country	Name	City	State
United States	Florida Hospital Global Robotics Institute	Celebration	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Apyx Medical	AdventHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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