A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 6
- 主要终点
- Diagnostic yield
研究概览
简要总结
The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.
详细描述
This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.
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
- •Subject is 18 years or older at the time of the procedure.
- •Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
- •Pulmonary nodule ≤2 cm in largest diameter.
- •Subject able to understand and adhere to study requirements and provide informed consent.
排除标准
- •Planned lymph node staging performed before nodule biopsy.
- •Nodule is a pure ground glass opacity.
- •Plan to biopsy multiple nodules.
结局指标
主要结局
Diagnostic yield
时间窗: Intra-procedure through the 13 month follow up period
Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied
Sensitivity for malignancy
时间窗: Intra-procedure through the 13 month follow up period
Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy
Rate of tool in nodule
时间窗: Intra-procedure
Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging)
次要结局
- Total radiation dose(Intra-procedure)
- Time to achieve tool in nodule(Intra-procedure)