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 patients should be deemed candidates for lobar resection if needed * Surgical candidates will be defined as: ** Patients 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. ** Patients without evidence of N2/N3 or metastatic disease, as upfront surgery would not typically be offered to such patient as part of their cancer-directed care. *** The absence of N2/N3 disease or metastatic disease will be confirmed by review of pre-operative positron emission tomography (PET)-CT and/or magnetic resonance imaging (MRI)s obtained as part of standard of care radiographic staging evaluation. *** The absence of N2/N3 disease will additionally 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.
• Participants 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 with and >= 0.5 cm from 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
• Patients 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)
• Patients in other therapeutic lung cancer studies
• Subject is pregnant or breastfeeding
• Coronavirus disease 2019 (COVID-19) positive patient at the time of procedure