Freeze and burn: new device targets lung cancer during bronchoscopy

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who require diagnostic bronchoscopy for suspicious lung lesions with mediastinal lymph node status confirmed as NO by one of the following: Prior PET-CT showing no FDG-avid mediastinal lymph nodes, OR intraoperative EBUS-TBNA with ROSE confirming negative lymph nodes (performed when clinically indicated per section 6.1). * Solitary pulmonary lesions ≤ 2.5cm with histologically or cytologically confirmed primary lung cancer. * Suitable candidate for surgical resection of the tumor targeted for ablation * Interdisciplinary tumor board consent * Ability to read, understand, and sign patient Informed Consent Form (ICF) * Age ≥ 18-years-old * ≥ 20 mm of free space between the calculated intended ablation zone and the lung parenchyma or any critical structures (pleura, vessels and main bronchi). Exclusion Criteria: * Pregnant or nursing (breast feeding) females * Central tumors abutting vital structures (main bronchus, pulmonary artery, esophagus, trachea) * Thoracic electronic implants (e.g., pacemakers, ICDs) * Uncorrectable coagulopathy or platelet count ≤ 50,000/mm³ * Patients receiving anticoagulant therapy or with pulmonary hypertension that, in the opinion of the Investigator, poses an unacceptable safety risk for bronchoscopy and ablation. * Severe, uncontrolled comorbidities * Active systemic infection * Prior radiation therapy (SBRT) in the intended ablation zone * Recent Investigational therapy within the last 30 days that the investigator deems could interfere with proceeding in the clinical investigation * Tumors associated with atelectasis, obstructive pneumonitis, pleural effusion, or fibrosis * Investigators determine that study participation poses safety risk * Any comorbidities judged by the principal Investigator to be contraindicated for bronchoscopy * Subject was judged unsuitable for study participation by the Investigator for any other reason