NCT06530667尚未招募不适用
A Prospective Clinic Study to Evaluate the Effectiveness Safety and Feasibility of the Broadband Collaborative Pulse Ablation Instrument in Treating Malignant Pulmonary Nodules
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2024年7月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Ablation success rate
研究概览
简要总结
Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules
详细描述
This clinical trial is to observe the safety and efficacy of the broadband synergistic pulse ablation device for treating malignant pulmonary nodules, and to provide reference data for the development of formal trials.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 18 and 70 years old with no gender limitation;
- •Malignant pulmonary nodules diagnosed by cytology and/or histopathology, or the number of tumors ≤
- •The pulmonary nodules were oligometastatic and the primary lesions were stable, with no uncontrolled metastasis to other sites;
- •Surgery is not available or the patient refuses surgical treatment;
- •Nodules' Maximum diameter≤2cm;
- •ECOG score≤2;
- •Patients understood the trial procedure and voluntarily signed informed consent.
排除标准
- •An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body;
- •Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time >18s, prothrombin activity <40%, platelet <80×109 /L);
- •Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;
- •Severe pulmonary fibrosis and pulmonary hypertension;
- •Patients with poor control of pleural effusion;
- •Patients with serious insufficiency of Liver, kidney, heart, lung, and brain function;
- •Patients with Severe anemia, dehydration, and severe disturbance of nutrient metabolism, which cannot be corrected or improved in the short term;
- •Patients with severe systemic infection, high fever (>38.5℃);
- •Pregnant and lactating women and those planning to become pregnant within one year;
- •Participants in clinical trials of any drugs and/or medical devices within 3 months before enrollment;
- •Any other factors that the investigator considers inappropriate for inclusion or that may affect the subject's participation in the study.
研究组 & 干预措施
treatment group
Experimental
Patients treated by broadband collaborative pulse ablation
干预措施: broadband collaborative pulse ablation (Device)
结局指标
主要结局
Ablation success rate
时间窗: 1 month after ablation
Ablation success rate = (numbers of nodule be completely ablated) / (numbers of nodule be ablated). Contrast-enhanced CT examination showed no significant enhancement of the nodule ablation area, and the nodule was considered to be completely ablated.
次要结局
- Complete ablation rate(3 months after ablation)
- Nodule recurrence rate(6 months after ablation)
- Nodule ablation time(Immediately after ablation)
- Adverse events(Up to 6 months)
研究者
研究点 (1)
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