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临床试验/NCT01666145
NCT01666145已完成不适用

Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Successful Insertion of Ablation Antenna Into Target Lesion

研究概览

简要总结

Advanced Image Guidance for this study was used during laparoscopic microwave ablation surgery to help the surgeon accurately place the ablation needle into the tumor of patients diagnosed with liver cancer.

详细描述

Hepatocellular carcinoma (HCC) is diagnosed in over 19,000 Americans annually and responsible for 17,000 deaths. Worldwide, (HCC) is the third leading cause of cancer death. Hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires repeated treatments and often results in progressively fewer treatment options because of severe underlying liver dysfunction. While surgery offers the best prognosis for such tumors and lesions, only 10-15% of all patients are candidates for removal by surgical means, necessitating the exploration of other treatment options. InnerOptic's AIM Guidance System is designed to alleviate the difficulty in using ultrasound to place a needle. AIM shows the needle and the ultrasound slice in their locations in 3D on a stereo monitor, making the spatial relationship between them obvious. AIM also displays the needle trajectory and where the needle will intersect with the ultrasound image, providing the surgeon with an indication of where the needle will go, if inserted along the needle shaft. AIM can also render an ablation volume guide, providing the surgeon with further confirmation that the needle is placed accurately and providing a volumetric guide regarding the power settings of the ablation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who have hepatocellular carcinoma.
  • Individuals who are candidates for microwave ablation surgery.

排除标准

  • Individuals who do not have hepatocellular carcinoma.
  • Individuals who are not a candidate for laparoscopic microwave ablation surgery.

结局指标

主要结局

Successful Insertion of Ablation Antenna Into Target Lesion

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.

Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.

次要结局

  • Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)(Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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