Cold Plasma for the Reduction of Lymphoceles Following PLND
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02658851|
Recruitment Status : Completed
First Posted : January 20, 2016
Results First Posted : December 2, 2020
Last Update Posted : December 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoceles Following Pelvic Lymph Node Dissection||Device: J-Plasma||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||June 27, 2017|
|Actual Study Completion Date :||June 27, 2017|
Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.
Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.
Other Name: Cold plasma
- Number of Participants With Incidence of Lymphocele Formation [ Time Frame: 12 weeks ]The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658851
|United States, Florida|
|Florida Hospital Global Robotics Institute|
|Celebration, Florida, United States, 34747|
|Principal Investigator:||Vipul R Patel, MD||Florida Hospital Global Robotics Institute|