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Cold Plasma for the Reduction of Lymphoceles Following PLND

NCT ID: NCT02658851

Last Updated: 2020-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-27

Brief Summary

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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.

Detailed Description

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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

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Lymphoceles Following Pelvic Lymph Node Dissection

Keywords

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lymphocele pelvic lymph node dissection robotic assisted radical prostatectomy PLND RARP prostatectomy Patel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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J-Plasma

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

Group Type EXPERIMENTAL

J-Plasma

Intervention Type DEVICE

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

Interventions

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J-Plasma

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

Intervention Type DEVICE

Other Intervention Names

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Cold plasma

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth

OTHER

Sponsor Role collaborator

Apyx Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vipul R Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Global Robotics Institute

Locations

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Florida Hospital Global Robotics Institute

Celebration, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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808076

Identifier Type: -

Identifier Source: org_study_id