A Multicenter, Randomized, Parallel-controlled Clinical Trial Protocol to Validate the Safety and Efficacy of a Steep Pulse Therapy System for the Treatment of Liver Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 30-day complete ablation rate
研究概览
简要总结
This clinical trial is a multicenter, randomized, parallel-controlled study. In this study, patients with liver cancer were selected as the research subjects, and the subjects were randomly divided into the experimental group and the control group. The experimental group used the steep pulse treatment system produced by Zhejiang CuraWay Medical Technology Co., Ltd., and the control group used the RF Ablation System produced by Covidien llc. A total of 5 or 9 visits were planned in this study, namely the screening period (-14-0 days), the day of the first ablation, 2 ± 1 days after the first ablation, 30 ± 5 days after the first ablation, and after the first ablation 90±7 days, the day of secondary ablation, 2±1 days after secondary ablation, 30±5 days after secondary ablation, and 90±7 days after secondary ablation. The complete ablation rate at 30 ± 5 days after the first ablation was used as the main efficacy evaluation index to evaluate the safety and efficacy of the steep pulse therapy system produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the patient is between 18-80 years old, and the gender is not limited.
- •For clinically diagnosed liver tumors, the diameter of a single tumor is less than or equal to 5cm; for multiple tumors: the number of tumors is not more than 3, and the largest tumor diameter is less than or equal to 3cm.
- •Patient is able to take care of himself, and ECOG performance status is between 0 and 2 points.
- •Liver function classification Child-Pugh A or B.
- •Expected survival period ≥ 6 months.
- •Patient is able to understand and comply with the trial protocol, and sign the informed consent.
排除标准
- •It is less than 30 days after the end of chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
- •Within 3 months after ablation, patients need to continue treatment with chemotherapy, radiation therapy, immunotherapy, targeted therapy, surgery, or other minimally invasive modalities.
- •patients with severe infectious diseases such as bacteremia and toxemia.
- •patients with uncorrectable coagulation dysfunction (PLT<40xl09/L).
- •patients with severe heart, brain, lung and other diseases, and patients with severe arrhythmia.
- •patients with implanted artificial hearts, lungs, internal pulse regulators or wearable medical electronic devices such as electrocardiography.
- •Patients with a history of epilepsy.
- •Patients with acute myocardial infarction within 6 months.
- •Pregnant and lactating women and those who plan to become pregnant within one year.
- •Those who are allergic to ultrasound, CT or MRI contrast agents.
- •Those who are contraindicated in general anesthesia.
- •Those who have participated in clinical trials of any drug or medical device within the first 3 months of the group.
- •The researchers believe that there are other factors that are not suitable for inclusion or that affect the participation of subjects in the study.
结局指标
主要结局
30-day complete ablation rate
时间窗: 30 days
Complete ablation rate
次要结局
- Equipment failure rate(1 day)
- Total complete ablation rate(90 days)
- Success rate of puncture(1 day)