Continuing Evaluation of the LungPoint ATV System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of serious adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer.
详细描述
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs. This feasibility study is being conducted to assess the safety and yield of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer. 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
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical candidates age 21-75 years at screening
- •Highly suspicious SPN, defined as distinct nodule with a diameter of 10-30 mm 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
- •Signs study-related informed consent document
排除标准
- •Any contraindication to bronchoscopy, for example: (a.) Untreatable life-threatening arrhythmias, (b.) Inability to adequately oxygenate the patient during the procedure, (c.) Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated), (d.) Recent myocardial infarction, (e.) Previously diagnosed high-grade tracheal obstruction, (f.) Uncorrectable coagulopathy.
- •Known coagulopathy
- •Platelet dysfunction or platelet count < 100 x 103 cells/mm3
- •History of major bleeding with bronchoscopy
- •Pulmonary hypertension with mean PAP >25 mm
- •Moderate-to-severe pulmonary fibrosis
- •Moderate to severe emphysema or COPD with FEV1 <60% predicted or RV >200% predicted
- •Bullae >5 cm located in vicinity of target SPN or ATV tunnel
- •Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example: (a.) ASA class > 3, (b.) > stage 3 heart failure, (c.) severe cachexia, (d.) severe respiratory insufficiency or hypoxia
- •Ongoing systemic infection
- •Contraindication to general anesthesia
- •Chronic use of anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel)
- •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.
- •Patients with known intrapulmonary metastases of extrapulmonary cancer/tumors
- •Scheduled for lung surgery within 7 days post-scheduled diagnostic bronchoscopy
结局指标
主要结局
Number of serious adverse events
时间窗: Up to 24 hours post procedure
The number of serious adverse events (SAEs) rated as probably or definitely related to the study device and/or procedure divided by the number of patients in whom an attempt at study device use was made. This study protocol focuses specifically on sub-chronic pneumothorax, but will also track hemoptysis.
次要结局
- Proportion of biopsies yielding tissue sufficient for diagnosis(Upon asssessment of histology of tissue sample taken during procedure)