Trial Outcomes & Findings for Cold Plasma for the Reduction of Lymphoceles Following PLND (NCT NCT02658851)

Last Updated: 2020-12-02

Results Overview

The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-12-02

Participant milestones
Measure	J-Plasma Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. 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.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Cold Plasma for the Reduction of Lymphoceles Following PLND

Baseline characteristics by cohort
Measure	J-Plasma n=100 Participants Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. 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.
Age, Continuous	63.28 Years STANDARD_DEVIATION 7.30 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Pre-Op Prostate-Specific Antigen (PSA)	7.97 ng/mL STANDARD_DEVIATION 5.23 • n=5 Participants
Pre-Operative Biopsy Gleason	7.45 units on a scale (Scale 2 - 10) STANDARD_DEVIATION 0.78 • n=5 Participants

Timeframe: 12 weeks

The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

Outcome measures
Measure	J-Plasma n=100 Participants Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. 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.
Number of Participants With Incidence of Lymphocele Formation	1 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Apyx Medical

Phone: 8012440058