AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule

Inclusion Criteria

• Subject with primary, treatment naïve, lung cancer (dominant nodule up to 3 cm) with diagnosis confirmed on previous pathology, intraoperative rapid on-site evaluation (ROSE), or intraoperative frozen section pathology. * Dominant nodule will be defined as the only nodule on the CT for which therapeutic intervention is thought indicated by the multidisciplinary team. * Non-dominant nodule(s) will be defined as any separate lung nodule(s) that are smaller than the dominant lung nodule and for which plan of the multi-disciplinary team plan is for further monitoring with CT chest rather than therapeutic intervention
• Target nodule/tumor which can be accessed via robotic bronchoscopy and confirmed location with cone beam CT scan intra-operatively
• Candidate for surgical resection as evaluated by a thoracic surgeon involved in their clinical care. While wedge resection is acceptable, all subjects should be deemed candidates for lobar resection if needed * Surgical candidates will be defined as: ** Subjects who otherwise have adequate cardiopulmonary status to undergo lung respective surgery as evaluated by a thoracic surgeon involved in their clinical care. *** Standard of care pulmonary functions test will be obtained prior to bronchoscopy as deemed necessary by treating surgeon. ** Subjects without evidence of nodal disease given that clinical concern for nodal disease indicates a patient population who stands to possibly benefit from standard of care neoadjuvant immunotherapy prior to surgical resection. *** The absence of nodal disease will be confirmed with clinically indicated minimally invasive mediastinal staging (e.g. endobronchial ultrasound bronchoscopy [EBUS]) which may be performed under the same general anesthesia session prior to the microwave ablation treatment.
• Subjects must be at least 22 years old and able to provide consent
• Tumor is >= 1 cm from the central bronchial tree (distal 2 cm of the trachea, carina, and named major lobar bronchi up to their first bifurcation)
• Lung lesion is not contiguous or touching the pleura/fissures

Exclusion Criteria

• Subjects in whom flexible bronchoscopy is contraindicated
• Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
• Pacemaker, implantable cardioverter, or another electronic implantable device
• Subjects with increased bleeding risk (e.g. prothrombin time [PT]/international normalized ratio [INR] > 1.5, platelets [PLTS] < 150 K, uninterruptable anticoagulation, uninterruptable dual antiplatelet therapy)
• Subjects in other therapeutic lung cancer studies
• Subject is pregnant or breastfeeding