A Single-Arm, Prospective, Multicenter Study to Evaluate the Effectiveness and Safety of the NeuWave Certus Microwave Ablation System in Chinese Patients With Primary or Secondary Tumors in the Lung

Ethicon, Inc.8 个研究点分布在 1 个国家目标入组 13 人2021年12月27日

适应症Cancer of the Lung

干预措施Microwave Ablation

概览

阶段: 不适用
干预措施: Microwave Ablation
疾病 / 适应症: Cancer of the Lung
发起方: Ethicon, Inc.
入组人数: 13
试验地点: 8
主要终点: Technical Efficacy Rate
状态: 终止
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors will all receive microwave ablation (MWA) performed percutaneously by doctors who are experienced in lung tumor ablation. 120 patients will participate across 8 clinical study sites all in China.

注册库

clinicaltrials.gov

开始日期

2021年12月27日

结束日期

2023年9月14日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Ethicon, Inc.

责任方

Sponsor

入排标准

入选标准

•Signed the informed consent form and willing to fulfill the study-related assessments and procedure schedule.
•Lung tumor patients ≥ 18 years of age who are ineligible for/decline surgery and who plan to receive microwave ablation therapy.
•ECOG performance status score of 0-
•Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients with clinically diagnosed oligometastatic lung tumor.
•Tumor(s) to be ablated in a single surgery should be a maximum of one NSCLC tumor or a maximum of three ipsilateral oligometastatic lung tumors.
•Tumor(s) to be ablated in a single surgery should be ≤ 2cm, locate in the outer two-thirds of a lung, not closer than 1 cm from the hilum of lung, great vessels, principal bronchus, trachea or esophagus, and not contiguous with the pleura.

排除标准

•Pregnant or breast-feeding.
•Patients with implantable pacemakers or other electronic implants.
•Oligometastatic tumors patients whose primary lesion cannot be controlled or have widely metastases, in the opinion of the investigator and/or treating oncologist.
•Any planned concurrent procedure at the time of ablation.
•Planned treatment for other tumors in the same side lung during the study period.
•With a skin infection or ulceration at the site to be punctured by probe(s).
•Clinical or imaging findings consistent with an active pulmonary infection.
•Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-induced pulmonary fibrosis.
•Patients with prior radiotherapy in the area intended to ablate.
•Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate.

研究组 & 干预措施

Microwave Ablation of Lung Tumor

Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors who plan to receive percutaneous microwave ablation.

干预措施: Microwave Ablation

结局指标

主要结局

Technical Efficacy Rate

时间窗: 30 days (+/- 7 days) post-ablation

Percentage of tumors that were completely covered by the ablation zone with no sign of pathological enhancement according to the lung contrast-enhanced CT assessment as assessed by the Independent Review Committee.