Needle-Based Confocal Laser Endomicroscopy to Aid in Lung Nodule Localization by Robotic-Assisted Navigational Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- 'Tool-in-lesion' positioning accuracy of nCLE during RANB biopsy.
研究概览
简要总结
This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN).
详细描述
Robotic-assisted navigational bronchoscopy (RANB) improves accuracy of lesion localization and diagnostic yield of the peripheral pulmonary nodule (PPN) biopsy compared to conventional flexible bronchoscopy. Needle based confocal laser endomicroscopy (nCLE) allows real-time microstructural imaging of lung nodule tissues at the needle tip. The study is designed to evaluate the safety and feasibility of utilizing nCLE during RANB biopsy procedure to optimize needle position and diagnostic accuracy, as well as reduce or replace the need for additional imaging tools such as radial endobronchial ultrasound (r-EBUS), cone beam computed tomography (CBCT), and/or fluoroscopy during RANB biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 22 years at signing of informed consent form (ICF).
- •Undergoing standard-of-care RANB for a solid lung nodule, which is considered to be at intermediate- to high-risk for malignancy as determined by the investigator per the institution's standard of care.
- •ICF signed before any study procedures are initiated.
排除标准
- •Medical contraindication to bronchoscopy under general anesthesia, or lack of physical fitness to undergo bronchoscopy under general anesthesia or to follow the study processes, as assessed by the investigator.
- •Presence of uncorrectable bleeding disorders, or anticoagulation/anti-platelet aggregation therapy that cannot be withheld for an appropriate interval prior to the procedure, as defined per the institution's standard of care.
- •Medical devices interfering with electro-magnetic navigation, including but not limited to pacemakers.
- •Subjects who have a target lesion that shows endobronchial involvement on chest CT.
- •Participation in any other clinical trial within 30 days of enrollment, that would interfere with this study.
- •Known hypersensitivity to fluorescein sodium or any other ingredients in the fluorescein product.
- •Planned surgical resection at the time of bronchoscopy
- •Female subjects who are pregnant or nursing at the time of the procedure.
研究组 & 干预措施
nCLE aided RANB biopsy
Single arm study
干预措施: nCLE aided RANB biospy (Device)
结局指标
主要结局
'Tool-in-lesion' positioning accuracy of nCLE during RANB biopsy.
时间窗: Intra-procedure
The accuracy of the positional relationship between the nCLE needle/probe and the index PPN will be determined using CBCT imaging.
次要结局
- Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy(Intra-procedure)
- Sensitivity of the real-time nCLE imaging assessment for malignancy(Intra-procedure)
- Diagnostic yield(up to 12 months post procedure)
- Sensitivity of the post-procedure nCLE image assessment for malignancy(Intra-procedure)
- Safety of nCLE aided RANB biopsy procedure(up to 30 days post procedure)