Clinical trial · Interventional
Cold Plasma for the Reduction of Lymphoceles Following PLND
Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoceles Following Pelvic Lymph Node Dissection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| J-Plasma | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- J-Plasma
- description
- Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.
- interventionNames
- Device: J-Plasma
Primary outcomes (1)
- measure
- Number of Participants With Incidence of Lymphocele Formation
- timeFrame
- 12 weeks
- description
- The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available