Safety and Feasibility of a Novel Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Positioning success rate
研究概览
简要总结
As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients
详细描述
This is a prospective, single-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 10 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.
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
- •Subjects should meet all of the following criteria
- •diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon.
- •commit to follow the research procedures and cooperate with the implementation of the whole process research
- •1 / 3 of pulmonary nodules are located in the periphery of the lung
- •signed informed consent with date
排除标准
- •the target lesion is close to the hilar or large blood vessels
- •subjects with FEV1 less than 1.2 in lung function
- •subjects with cardiac function III and cardiac function IV (NYHA, New York)
- •subjects with uncontrollable acute pleura infection
- •patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side
- •Other factors that investigators disagree enrollment.
结局指标
主要结局
Positioning success rate
时间窗: Immediately after resection
When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful. The success rate is the proportion of successful cases to all operation cases
次要结局
- Complications(One month)
- Procedure time(Duration of procedure)
研究者
Hecheng Li M.D., Ph.D
Chair of thoracic department
Ruijin Hospital