ANET Electrosurgery Applicator Pilot Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 8
- 主要终点
- ANET Related Peri-procedural Adverse Events
研究概览
简要总结
Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.
详细描述
This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects.
Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor
- •Pathological proof of target nodule/tumor type and malignancy
- •Target nodule/tumor which can be accessed via EBUS bronchoscopy
- •Resection/surgical candidate
- •Participants must be at least 18 years old and able to provide consent
- •Exclusion criteria:
- •Subjects in whom flexible bronchoscopy is contraindicated
- •Target nodule < 1.0 cm
- •Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
- •Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
- •Pacemaker, implantable cardioverter, or other electronic implantable device
排除标准
- 未提供
结局指标
主要结局
ANET Related Peri-procedural Adverse Events
时间窗: Day 0
The incidence of reported adverse events and serious adverse events related to the ANET device or procedure
次要结局
未报告次要终点