A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Sensitivity for malignancy
研究概览
简要总结
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.
详细描述
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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 was 18 years or older at the time of the procedure
- •Biopsy procedure attempted/performed using the Ion Endoluminal System
排除标准
- •Biopsy procedure was not attempted with the Ion Endoluminal System
- •Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval
结局指标
主要结局
Sensitivity for malignancy
时间窗: Intra-operative through the one year follow up period
Sensitivity for malignancy of the sample obtained
Pneumothorax
时间窗: Intra-operative
Incidence of all pneumothoraces related to the Ion procedure
Diagnostic yield
时间窗: Intra-operative through the one year follow up period
Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)
Bleeding
时间窗: Intra-operative
Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission.
次要结局
- Adverse events(Intra-operative through 30 days)
- Conversion to alternate approach or termination of procedure(Intra-operative)