Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy
研究概览
简要总结
The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.
排除标准
- •Pulmonary nodules less than 1.0 cm
- •patients must be able to tolerate general anesthesia
- •patients with significant coagulopathy having International Ratio (INR)>2.0 or Prothrombin Time (PTT) >2x normal
- •patients unable to tolerate bronchoscopy
- •pregnant patients or patients who believe they are pregnant
- •patients with implantable devices susceptible to Radio Frequency (RF) fields
- •severely obese patients
研究组 & 干预措施
Navigational Bronch/Standard Bronch
Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
干预措施: Navigational Bronchoscopy (Procedure)
Navigational Bronch/Standard Bronch
Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
干预措施: Standard Bronchoscopy (Procedure)
Standard Bronch/Navigational Bronch
Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.
干预措施: Navigational Bronchoscopy (Procedure)
Standard Bronch/Navigational Bronch
Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.
干预措施: Standard Bronchoscopy (Procedure)
结局指标
主要结局
Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy
时间窗: up to 1 year
This information will be gathered from the pathology report. This report will be completed as soon as possible after the procedure.
次要结局
- Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules(up to 1 year)
- Total procedure time(Day 1)
- Total virtual bronchoscopy time(Day 1)