Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study

Korábbi kezelés

• Patient is receiving concurrent cancer treatment (e.g., external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy).
• Patient has received effective treatment for the target lesion in the last two years prior to the date of consent.
• Patient has undergone prior pneumonectomy.
• Patient has a serious medical condition that, in the Principal Investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to PEF ablation (e.g., major organ dysfunction, active autoimmune disease, immune compromised or receiving immune modulating medication that has resulted in substantial clinical change).
• Patient is receiving oral corticosteroid therapy (>10mg/day or equivalent) within 30 days of the PEF procedure.

Más betegség

• Patient requires neoadjuvant therapy for the disease for which surgical resection is intended.
• Patient has a physical or psychological condition that would impair study participation or jeopardize the safety or welfare of the patient.

Egyéb

• Patient is currently enrolled in another interventional clinical trial.
• Women of childbearing potential who are pregnant, nursing, or planning to get pregnant during their participation in the study.

• Presence of at least one lesion in the lung measuring ≥ 1.5 cm and ≤ 4 cm diameter by computed tomography (CT) size estimate deemed suitable for PEF ablation per institutional guidelines.
• High probability of malignancy as determined by the investigator.
• Patient has been deemed a candidate for definitive lung tissue resection per institutional SOC.
• Patient is, in the opinion of the Principal Investigator (PI), able to adhere to and undergo the PEF and surgical procedures.
• Patient is able to tolerate general anesthesia.
• Patient is 18 years of age or older.
• Patient has provided informed consent.