N/A
N=100
Cold Plasma for the Reduction of Lymphoceles Following PLND
Lymphoceles Following Pelvic Lymph Node Dissection
Bottom Line
View on ClinicalTrials.gov: NCT02658851 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Incidence of Lymphocele Formation — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- J-Plasma (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Apyx Medical
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incidence of Lymphocele Formation |
1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02658851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.