NCT04702165已完成1 期
Image - Navigated Resection of Lung Nodules
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To compare the measurements from the J-bar fiducial to the first staple line obtained by the device in vivo to that performed in the frozen section room on the lung specimen obtained (which includes both the J bar and the staple line).
研究概览
简要总结
This is an open label study lung nodules that are either cancer or non-cancer and who are eligible for surgical resection. Patients will undergo their surgery with the help of the Lung Resection Marker Locator Kit which will assist the surgeon in both the location and resection of the lung nodule under real-time guidance.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 21 years or older as it is extremely rare for younger people to be at risk for lung cancers.
- •Be deemed candidates for the lung resection surgery, which will be determined by their treating Thoracic Surgeon (also a physician investigator)
- •Have lesions that are nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension using conventional techniques
- •Seen at BWH Thoracic Surgery outpatient clinics or as inpatient (Note: Subjects will be formally consented to the study at BWH only)
排除标准
- •Female subjects pregnant or breastfeeding
- •Subjects with a pacemaker or equivalent devices (AICD) due to the use of electromagnetic tracking generator.
- •Patients who are not scheduled for lung surgery
结局指标
主要结局
To compare the measurements from the J-bar fiducial to the first staple line obtained by the device in vivo to that performed in the frozen section room on the lung specimen obtained (which includes both the J bar and the staple line).
时间窗: 1 day
device feasibility
次要结局
- demonstrate safe surgical remove of lung nodule(30 day)
- time required for device placement(1 day)
- whether coefficient is needed(1 day)
研究者
研究点 (2)
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