A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 9
- 主要终点
- Diagnostic Yield
研究概览
简要总结
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
详细描述
This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.
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
- •Patient is aged 18 years or older at time of consent.
- •Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal system.
- •Patient is willing and able to give written informed consent for clinical study participation.
排除标准
- •Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
- •Female patient that is pregnant or breast feeding as determined by standard site practices.
- •Patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor.
- •Patient is not willing to comply with post-procedure study participation requirements.
- •Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.
研究组 & 干预措施
Observation Group
Subjects with biopsy and/or localization of lung nodule(s)
干预措施: Ion endoluminal system (Device)
结局指标
主要结局
Diagnostic Yield
时间窗: Intra-procedure through 24 month post-procedure
Diagnostic Yield 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
- Pneumothorax(Intra-procedure through 30 days post-procedure)
- Bleeding(Intra-procedure through the 30 day post-procedure)