Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion
研究概览
简要总结
A post-market study to assess the performance and safety of a RF ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lung cancer or metastatic lung lesions who are scheduled for surgical resection.
详细描述
This study is a prospective, single-arm, multi-center, post-market study of bronchoscopic radio frequency (RF) ablation treatment malignant lung lesions prior to surgical resection. Up to 15 patients will be treated at the participating sites.
Patients identified for the study will have been scheduled for surgical resection as part of their treatment for lung lesions. The RF ablation procedure will be performed during a standard-of-care bronchoscopic procedure at minimum of 24 hours prior to resection. The patients exits the study following surgical resection. The resected tissue will undergo pathological evaluation for tissue viability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 at screening
- •Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor
- •Eligible for standard of practice lung resection (pneumonectomy, lobectomy)
- •Tumor/lesion > 2cm along the major diameter with no visible necrosis
- •Signed informed consent form
排除标准
- •An implantable pacemaker, defibrillator, or other active implants
- •Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation
结局指标
主要结局
Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion
时间窗: The interval between ablation and tissue resection for pathological analysis is a minimum of 24 hours, but the exact interval depends on the investigator's standard of care
Maximum diameter (in mm) of ablation zone (thermal necrosis) surrounding treated lesion as measured in resected tissue by quantitative histopathological and gross pathological analysis
Performance - ability of the user and device to deliver ablative treatment in accordance with the catheter's Instructions for Use
时间窗: Assessed at the time of the RF ablation procedure
The ability of the ablation treatment to be delivered as per the Instructions for Use will be assessed using a binary categorical scale (yes/no)
Safety - Adverse events (AEs) and serious adverse events (SAEs)
时间窗: AEs and SAEs related to the RF procedure/device will be reported for the interval beginning with the RF ablation procedure and ending with the surgical resection of the ablated lung tissueion
The incidence of reported adverse events and serious adverse events related to the RF ablation procedure/device
次要结局
未报告次要终点