Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of Participants With Incidence of Lymphocele Formation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of Participants With Incidence of Lymphocele Formation
时间窗: 12 weeks
The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.
次要结局
未报告次要终点