Prospective Multi-center Study Using a Bronchoscopic Ultrasound-Guided Needle Biopsy System With Real-time Visualization in Endobronchial Lesions, Peripheral Lung Nodules, or Lung Masses
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Proportion of patients where the needle is visualized by the iNOD system inside the lesion
研究概览
简要总结
The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.
详细描述
This post-market study intends to further demonstrate the ability and safety of the iNod™ Ultrasound Guidance System and iNod™ Ultrasound Biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. This is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age 18 years or older.
- •Subject willing and able to comply with study procedures and provide written informed consent to participate in study.
- •Subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial CT imaging (obtained within 4 weeks per standard of practice) with the intention to undergo a clinically indicated bronchoscopic evaluation under routine clinical care. If the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up at least 80% of the lesion.
- •a. "Peripheral" lesion in this study will be pragmatically defined as any lesion in the lung parenchyma that the clinician feels cannot be accessed successfully using the convex probe endobronchial ultrasound bronchoscope.
- •Subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject.
排除标准
- •Subjects with pure ground glass opacity or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by Chest CT.
- •Subjects who have medical contraindication to undergo conventional flexible or robotic bronchoscopy and standard of care Radial EBUS-guided cytological assessment evaluations, as determined by the investigator.
- •Subjects with known coagulopathy.
- •Subjects who are pregnant or nursing mothers.
- •Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
- •Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy
结局指标
主要结局
Proportion of patients where the needle is visualized by the iNOD system inside the lesion
时间窗: Procedure
Successful "Tool in lesion", defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view.
Adverse Events
时间窗: Procedure
Proportion of subjects with Adverse Events related to the iNod device and/or study procedure, as well as Adverse Events related to any subsequent crossover procedures.
次要结局
未报告次要终点