Cold Plasma for the Reduction of Lymphoceles Following PLND

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Apyx Medical

Status

Completed

Conditions

Lymphoceles Following Pelvic Lymph Node Dissection

Treatments

Device: J-Plasma

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02658851
808076

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

J-Plasma
Experimental group
Description:
Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.
Treatment:
Device: J-Plasma

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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