Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Exclusion Criteria26

• 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.