A Multicenter, Single Group Target Value Clinical Study to Evaluate Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Complete ablation rate of main lesions at 6 months
研究概览
简要总结
It is a multicenter, single group target value clinical trial to evaluate the safety and effectiveness of radiofrequency ablation for peripheral lung tumors under the conjunction of the pulmonary radiofrequency ablation system with the disposable pulmonary radiofrequency ablation catheter developed by Hangzhou Broncus Medical Co., Ltd.
详细描述
The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter. During the study, eligible subjects will be followed up intraoperatively, 24 hours after operation, before discharge/ 7 days after operation (whichever occurs first), 30 days (±7 days) after operation, 3 months (±7 days) after operation, 6 months (±15 days) after operation, 9 months (±15 days) after operation, and 12 months (±15 days) after operation.
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
- •Age ≥ 18 years old;
- •Planned ablated main lesions are pathologically confirmed and other planned ablated lesions are pathologically confirmed or clinical evaluated as primary NSCLC or pulmonary metastasis, and the primary lesions of lung metastasis subjects has been well controlled;
- •Number of unilateral lung lesions: ≤ 3 (excepting for multiple primary lung cancers);
- •Each lung lesion in size: ≤3 cm ;
- •Subjects refuse surgery or are considered intolerant of surgery;
- •Subjects refuse or are considered unsuitable for radiotherapy/chemotherapy, or are non-responders for previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy;
- •It is feasible to arrive at the target lesions through bronchus path and carry out ablation operations, assessed by investigators;
- •Subjects whose Eastern oncology cooperative group (ECOG) physical state score: ≤3;
- •Subjects agree to undergo radiofrequency ablation to treat pulmonary lesions.
排除标准
- •Subjects with severe bleeding tendency and irreversible clotting disorders; or subjects who have stopped anticoagulation therapy and/or antiplatelet drugs for less than 7 days before ablation;
- •Subjects whose preoperative examination within 1 month shows intrathoracic lymph node or extra-pulmonary metastasis (except for extra-pulmonary metastasis controlled by local therapy);
- •Planned ablated lesions have received radiotherapy within past 6 months;
- •Subjects with high-risk disease for ablation operation;
- •The nearest distance between the tumors and trachea, main bronchial tube, esophagus, aortic arch branch, main pulmonary artery, left and right pulmonary artery and the heart is less than 2cm;
- •Subjects who have participated in the last 30 days or is participating in other clinical studies;
- •Subjects who are pregnant or have pregnancy plan during the study;
- •Subjects with bronchoscopy contraindications;
- •Subjects with implantable cardiac pacemakers, implantable defibrillators, or other active implants;
- •Subjects with general anesthesia contraindications;
- •Subjects with other conditions that need to be excluded as determined by investigators.
结局指标
主要结局
Complete ablation rate of main lesions at 6 months
时间窗: Six months
Six months after the overall ablation procedure, the proportion that subjects whose main lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
次要结局
- Quality of life (QoL)(Twelve months)
- Complete ablation rate at 6 months (in terms of subjects)(Six months)
- Complete ablation rate at 12 months (in terms of ablation lesions)(Twelve months)
- Technical success rate (in terms of ablation operations)(Immediately after Each Operation)
- Intrapulmonary progression-free survival rate at 6 months(Six months)
- Intrapulmonary progression-free survival rate at 1 year(Twelve months)
- Complete ablation rate at 6 months (in terms of ablation lesions)(Six months)
- Complete ablation rate at 12 months (in terms of subjects)(Twelve months)
- Overall survival rate (OS) at 1 year(Twelve months)
- Safety(Twelve months)