NCT02867371已完成不适用
Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 16
- 主要终点
- Proportion of biopsies yielding tissue sufficient for diagnosis
研究概览
简要总结
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-75 years at screening
- •Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ≥8mm in its largest dimension
- •No known endobronchial tumor
- •Tumor located anywhere in parenchymal tissue >1 cm from pleura and accessible bronchoscopically through a POE.
- •Willing to participate in all aspects of study protocol for duration of study
- •Able to understand study requirements
- •Subject or legally authorized representative signs study-related informed consent document
排除标准
- •Any contraindication to bronchoscopy, for example:
- •Untreatable life-threatening arrhythmias
- •Inability to adequately oxygenate the patient during the procedure
- •Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
- •Recent myocardial infarction
- •Previously diagnosed high-grade tracheal obstruction
- •Uncorrectable coagulopathy
- •Known coagulopathy
- •Platelet dysfunction or platelet count < 100 x 103 cells/mm3
- •History of major bleeding with bronchoscopy
- •Suspected pulmonary hypertension: additional testing required, such as echocardiogram
- •Moderate-to-severe pulmonary fibrosis
- •Severe emphysema or COPD: additional testing and PI consent is required
- •Bullae >5 cm located in vicinity of target nodule or tunnel
- •Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:
- •ASA class > 3
- •> stage 3 heart failure
- •severe cachexia
- •severe respiratory insufficiency or hypoxia
- •Ongoing systemic infection
- •Contraindication to general anesthesia
- •Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
- •Participation in any other study in last 30 days
- •Prior thoracic surgery on the same side of the lung as the SPN.
- •Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
- •Life expectancy of less than one year.
- •Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
- •Prior radiation therapy treatment in the target lobe
研究组 & 干预措施
-Navigation and tissue sampling
Experimental
Guided bronchoscopic navigation and lung tissue sampling using the Archimedes System
干预措施: Archimedes System (Device)
结局指标
主要结局
Proportion of biopsies yielding tissue sufficient for diagnosis
时间窗: Up to 1 year
The number of nodules with at least one biopsy sufficient for a definitive tissue diagnosis divided by the number of nodules sampled by the Archimedes System.
次要结局
- Patient registration time(Up to 1 year)
- Procedure planning time(Up to 1 year)
- Fluoroscopy time(Up to 1 year)
- Nodule access time(Up to 1 year)
研究者
研究点 (16)
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