Cold Plasma for the Reduction of Lymphoceles Following PLND
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/3/2016 |
| Start Date: | June 2016 |
| End Date: | July 2017 |
| Contact: | Cindy Ponce |
| Email: | cindy.ponce@boviemed.com |
| Phone: | (770)367-8173 |
Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
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.
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.
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.
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.
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.
We found this trial at
1
site
Celebration, Florida 34747
Principal Investigator: Vipul R Patel, MD
Phone: 407-303-4933
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