Investigator-Initiated Feasibility Study of a Novel Endoscopic Ultrasound Guided Microwave Ablation Device in Patients With Locally Advanced, Unresectable, or Metastatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- To assess the success of energy delivery during treatment with the device
研究概览
简要总结
The goal of this study is to assess the overall success of energy delivery during treatment using the ultrasound guided microwave ablation device in patients with locally advanced, unresectable, or metastatic cancer. Secondly, this study aims to explore the procedural/clinical safety of treatment with the device and the antitumor effect following treatment with the device.
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
- 否
入选标准
- •Male or female ≥18 years of age
- •Willing and able to provide written informed consent
- •Histologically confirmed locally advanced, unresectable or metastatic cancer (Stage III or IV)
- •At least 1 tumor that is indicated for MWA, and the location of target tumor must be accessible via EUS through the gastric wall (eg, pancreas, liver, etc).
- •The tumor(s) must be ≥1 cm in diameter
排除标准
- •Participant is a candidate for upfront resection of pancreatic cancer
- •Participation in another clinical trial that involves local ablation or any other local therapy that could affect the target organ or lesions treated in this study
- •Any condition that, in the opinion of the investigator, may increase the risk to the participant's safety or well-being
研究组 & 干预措施
Endoscopic Ultrasound (EUS) - Guided Microwave Ablation (MWA) Device Group
This is a open label feasibility study and only eligible participants will be enrolled into the single arm of the study to receive MWA with this specific device.
干预措施: EUS-Guided MWA Device (Device)
结局指标
主要结局
To assess the success of energy delivery during treatment with the device
时间窗: From first MWA procedure to the end of treatment at Week 5 or 9
Success of energy delivery as measured by presence of echogenic microbubbles visualized during EUS imaging AND generator-confirmed energy delivery.
次要结局
- To evaluate the procedural safety(From first MWA treatment to final long term follow up at week 52)
- To evaluate clinical safety(From first MWA treatment to final long term follow up at week 52)
- To evaluate tolerability of treatment with the device(From first MWA treatment to final long term follow up at week 52)
- To evaluate the early antitumor effect of treatment with the device by change in size of target lesion.(From first MWA treatment to follow up visit at 6 months from first treatment)
- To evaluate the early antitumor effect of treatment with the device by RECIST.(Time Frame: From first MWA treatment to follow up visit at 6 months from first treatment)