LungPoint ATV for Biopsy in Patients Undergoing Lobectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Ability to complete procedure using system
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.
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 ability of the investigator to access and sample tissue using this system in patients undergoing lobectomy or pneumonectomy. Navigation to and sampling of the patient's lung cancer tumor is conducted immediately prior to the scheduled lobectomy or pneumonectomy.
Note: This study was conducted as a single-center feasibility clinical trial to determine the feasibility of this device. The primary outcome measures related only to feasibility and not to health outcomes. Therefore it was not registered on clinicaltrials.gov prior to the start of enrollment. Subsequently, it was determined that the results were compelling and therefore it was registered to facilitate publication.
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
- •Known or suspected lung cancer or intrapulmonary metastatic disease with SPN greater than 10 mm and less than 40mm in 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
结局指标
主要结局
Ability to complete procedure using system
时间窗: At completion of procedure
The proportion of cases (attempted nodules) in which the procedure could be substantially completed by the investigator divided by the number of cases (nodules) for which at least one attempt to pass any LungPoint study device into the bronchoscope was made.
次要结局
- Proportion of nodules biopsied yielding tissue sufficient for diagnosis(Upon asssessment of histology of tissue sample taken during procedure)
- Number of significant adverse events(Up through lobectomy of lobe at end of procedure)