NCT06158971招募中不适用
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety - AE frequency
研究概览
简要总结
Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.
详细描述
This study is a prospective, single-arm, single-center, study to evaluate the safety and technical feasibility of using the phenoWave MW Ablation System to deliver microwave energy for ablation of lesions in the lung.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-77 years at screening.
- •Confirmed NSCLC or solitary metastatic (oligometastatic) or pulmonary metastases from an extra thoracic primary tumor lung nodule through diagnostic biopsy
- •Must be eligible for curative lung resection (lobectomy).
- •For primary tumor, pre-ablated parenchymal tumor/lesion size ≥ 20 mm if NSCLC, or ≥ 10 mm for metastatic disease in diameter as measured from pre-operative CT image.
- •Willing to participate in all aspects of study protocol for duration of study.
- •Able to understand study requirements.
- •Signs informed consent form.
- •Boundary of tumor is at least 15 mm away from the pleura wall and/or fissure.
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.
- •Uncorrectable coagulopathy.
- •Known coagulopathy.
- •Platelet dysfunction or platelet count < 100 x 109 cells/L OR taking anticoagulant or antiplatelet agents that cannot be safely ceased in the opinion of the pulmonologist or surgeon.
- •History of major bleeding with bronchoscopy.
- •Suspected pulmonary hypertension.
- •Moderate-to-severe pulmonary fibrosis.
- •Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD) within 3cm of tumor/lesion boundary: prior COPD assessment data is evaluated and PI consent is required.
- •Bullae >5 centimeter (cm) located in vicinity of target tumor/lesion.
- •Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic MWA, for example:
- •American Society of Anesthesiologists (ASA) physical status classification >P3
- •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.
- •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 6 months.
- •Prior radiation therapy treatment in the target lobe.
- •Implantable pacemaker or defibrillator.
结局指标
主要结局
Safety - AE frequency
时间窗: up to 7 days post ablation
Frequency of AEs
Safety - AE occurrence
时间窗: up to 7 days post ablation
Incidence of complications and occurrence of Adverse Events (AEs)
Technical Feasibility
时间窗: up to 7 days post ablation
Evidence of thermal ablation in portion of the tumor as assessed on histopathology
Safety - ablated tissue assessment
时间窗: up to 7 days post ablation
Percentage of ablated tissue within tumor boundary as assessed on gross and/or histologic evaluation
次要结局
- Navigational Success(Immediately after completion of procedure (day 0))
- Procedural Measures(Immediately after completion of procedure and navigation to the target (day 0))
研究者
研究点 (2)
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