Ensayos clínicos

Inclusion Criteria:

• Subject or authorized representative has provided informed consent.
• Subject is ≥18 years of age.
• At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter.
• Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation.
• Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
• ≥1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure.

Exclusion Criteria:

• Pre-procedure Exclusion Criteria
• Contraindicated for surgery.
• Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
• Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
• Tumor with pleural contact.
• Tumors located < 3 cm of staple lines or other metal objects.
• Patients diagnosed with GOLD Stage IV Emphysema.
• Uncontrollable coagulopathy
• Patients unable to tolerate discontinued use of anti-coagulants prior to and during the ablation procedure.
• Subject is pregnant (documented by a positive pregnancy test according to hospital standard practices) or is actively breast-feeding.
• Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study.
• The investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
• Patients with implantable pacemakers and other electronic implants, in accordance with Instructions for Use (IFU).

Intraprocedural Exclusion Criteria

• Incidental intraprocedural finding that the subject no longer meets the study eligibility criteria.