Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions
研究概览
简要总结
To evaluate the feasibility of the Fraxinus Virtual Bronchoscope Navigation (VBN) System in the bronchoscopic access to target lesions. The study emphasizes the system´s efficacy in diagnostics of peripheral pulmonary lesions and the ease of use for the operator.
详细描述
Multi-center study. The study explores Fraxinus which is an open source, software only, simple guiding system for bronchoscopy. The system provides 3D maps with centerline-to-target information extracted from preoperative computed tomography. The ability of the system to guide a user to a peripheral target lesion will be evaluated. During bronchoscopy any established method for diagnostic sampling is allowed. User Evaluation will be essential to decide if the Fraxinus VBN System is beneficial in a clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •referred to thoracic department in any of the participating hospitals with undiagnosed peripheral pulmonary lesion(s) not visible by bronchoscopy
- •voluntary signed an informed consent
排除标准
- •pregnancy
- •Any patient that the Investigator feels is not appropriate for this study for any reason
结局指标
主要结局
Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions
时间窗: 48 hours
The proportion of cases in which the use of the system is considered beneficial
次要结局
- Adverse events(48 hours)
- Operators-reported satisfaction(48 hours)
- Duration of procedure(48 hours)
- Diagnostic yield(1 week)