Clinical Product Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures
研究概览
简要总结
To evaluate the role of the LungPoint VBN System in the bronchoscopic access to a target location.
The evaluation will explore:
- Ability of the system to guide a user to one or more target site(s)
- Ease of use of the system (assessment of the user interface)
- Incremental value brought by the use of the system to the successful completion of a case.
详细描述
Multi-center, prospective, single-arm study. The Study will take the form of a User Evaluation. The Evaluation will require the user to perform several standardized functions (e.g. peripheral lesion sampling, lymph node sampling). In addition, users will be asked about other potential techniques that fall within the intended use of the device.
The evaluation will be conducted in patients who are indicated for procedures that fall within the intended use of the device. Examples of such patients include:
- Patients who have been recommended for bronchoscopy for the purpose of obtaining a biopsy sample of a central or peripheral pulmonary lesion.
- Patients who have been recommended for bronchoscopy for the purpose of diagnosing mediastinal or hilar lymphadenopathy.
- Patients who have been recommended for bronchoscopy for the purpose of lung fiducial placement.
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
- 是
入选标准
- •Subject has provided Informed Consent
- •Subject is scheduled for bronchoscopy for the purpose of diagnosing: a central or peripheral pulmonary nodule or mass, infiltrative disease, mediastinal or hilar lymphadenopathy, or placing fiducial markers.
- •Subject has a CT scan that is consistent with high-resolution specifications
排除标准
- •Patients less than 18 years of age.
- •Any patient that the Investigator feels is not appropriate for this study for any reason.
结局指标
主要结局
Evidence that LungPoint VBN has a clear role in targeted bronchoscopic procedures
时间窗: Immediate post-operative (day 0)
次要结局
未报告次要终点