A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Successful Navigation to the lesion
研究概览
简要总结
A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
详细描述
The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients with indeterminate lung nodule
- •Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT
- •Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
- •Informed consent properly obtained per local regulations
排除标准
- •Known pregnancy or breastfeeding
- •Patients with pure ground-glass nodules on pre-procedural chest CT
- •Uncontrolled coagulopathy or bleeding disorders
- •Ongoing systemic infection
- •History of lobectomy or pneumonectomy
- •Patients with pacemakers or defibrillators
- •Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist
- •Patients with pleural effusion or diaphragmatic paralysis
结局指标
主要结局
Successful Navigation to the lesion
时间窗: During the procedure
Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy.
Successful tool-in-lesion
时间窗: During the procedure
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Serious Adverse Events
时间窗: During the procedure and up to 7 days post procedure
Serious device or procedure related adverse events
次要结局
- Diagnostic yield(End of procedure and up to 2-years post-procedure)
- Center Strike(During the procedure)