A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,301
- 试验地点
- 32
- 主要终点
- Primary Endpoint to Assess Diagnostic Yield
研究概览
简要总结
The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.
详细描述
This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.
Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.
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
- •Subject is 18 years or older at the time of the index procedure.
- •Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
- •Subject able to understand and adhere to study requirements and provide informed consent.
排除标准
- •Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
- •Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
- •Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
- •Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.
研究组 & 干预措施
Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System
Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.
干预措施: Ion Endoluminal System (Device)
结局指标
主要结局
Primary Endpoint to Assess Diagnostic Yield
时间窗: Intra-procedure through the 24 month follow up period
Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
次要结局
- Secondary Endpoint to Assess Bleeding(Intra-procedure through the 30 day follow up period)
- Secondary Endpoint to Assess Pneumothorax(Intra-procedure through the 30 day follow up period)