Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.