Lymphoceles Following Pelvic Lymph Node DissectionNCT02658851

Cold Plasma for the Reduction of Lymphoceles Following PLND

A study testing J-Plasma in people with Lymphoceles Following Pelvic Lymph Node Dissection, run by Apyx Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Lymphoceles Following Pelvic Lymph Node Dissection
What is being tested?: J-Plasma
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Jun 2016to 27 Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida Hospital Global Robotics Institute
Celebration, Florida, 34747

Other trials in United States

About this study

Official title: 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.

Read the detailed 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.

Conditions: Lymphoceles Following Pelvic Lymph Node Dissection
Being tested: J-Plasma
Keywords: lymphocele, pelvic lymph node dissection, robotic assisted radical prostatectomy, PLND, RARP, prostatectomy, Patel
Medical subject headings: Lymphocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

J-PlasmaDevice
Also called Cold plasma
Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

Study groups in NCT02658851
Study group	Role	What they receive
J-Plasma	Experimental	Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. Receives: Device: J-Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Incidence of Lymphocele Formation
The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201627 Jun 2017

First posted20 Jan 2016 (estimated)
Study startJun 2016
Primary completion27 Jun 2017
Study completion27 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lymphoceles Following Pelvic Lymph Node DissectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02658851
Sponsor's protocol ID: 808076
Status last verified: Dec 2020
First submitted: 15 Jan 2016
Last updated: 2 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
ClinicalTrials.gov ID: NCT02658851
Acronym / sponsor ID: 808076
Conditions: Lymphoceles Following Pelvic Lymph Node Dissection
Keywords: lymphocele, pelvic lymph node dissection, robotic assisted radical prostatectomy, PLND, RARP, prostatectomy, Patel
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Apyx MedicalIndustry (pharma, biotech, devices)
Collaborators: AdventHealth
Study start: Jun 2016
Primary completion: 27 Jun 2017 (actual)
Study completion: 27 Jun 2017 (actual)
First posted: 20 Jan 2016 (estimated)
Results: Posted 2 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
J-Plasma	Experimental	Device: J-PlasmaEnrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
J-PlasmaAlso: Cold plasmaBovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.	Device	J-Plasma

Primary outcome

Number of Participants With Incidence of Lymphocele Formation
Time frame: 12 weeks
The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

Results and safety

Results posted to the registry on 2 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
J-Plasma	100	100

Primary outcome: Number of Participants With Incidence of Lymphocele Formation

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	J-Plasma n = 100
Value	1

Adverse events

Time frame: Adverse events were collected beginning at the day of surgery and collected to the 8 week follow-up visit (8 weeks, +/- 4 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
J-Plasma	0 of 100 (0%)	0 of 100 (0%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vipul R Patel, MD principal investigator

Florida Hospital Global Robotics Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing J-Plasma in people with Lymphoceles Following Pelvic Lymph Node Dissection, run by Apyx Medical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Incidence of Lymphocele Formation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658851.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.