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临床试验/NCT04106453
NCT04106453已完成不适用

Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial

Universitätsklinikum Köln2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
time to complete ablation

研究概览

简要总结

In primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.It could be performed laparoscopically. Under ultrasound control the microwave device is placed in the tumor.Therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. During learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. Targeting systems could optimize that. The CasOne-SPOT-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. In this study targeting precision using the SPOT-System should be compared to conventional laparoscopic ultrasound-guided microwave ablation. Therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. The ablation procedures will be performed by two novices and two experienced surgeons. Aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the SPOT-navigation system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation

排除标准

  • 未提供

结局指标

主要结局

time to complete ablation

时间窗: 0-10 minutes

time from beginning of the targeting process until to complete ablation of the tumor mimic

次要结局

  • ablation completeness(up to 1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roger Wahba, MD, PhD

Principal Investigator

Universitätsklinikum Köln

研究点 (2)

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