Overview
A prospective, single-arm, non-randomized, single-center, open-label, treat and resect study following patients through surgical resection. The study is designed to evaluate the safety and feasibility of the Aliya EX System for the ablation of pulmonary lesions using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed pulmonary malignant lesion(s) ≥1.5 cm to ≤4 cm whom are surgical candidates and have not received treatment for the index tumor in the last two years.
Description
This study is to evaluate the safety and technical success of delivering Aliya® pulsed electric fields (Aliya PEF) for ablation of pulmonary lesions in patients with suspected or confirmed malignancy, prior to planned surgical resection.
Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations:
Bronchoscopic approach: Aliya® EX Generator, the INUMI Flex Needle and the Aliya® Electrode.
Percutaneous approach: Aliya® EX Generator, the Aliya® Needle and the Aliya® Electrode.
The study will enroll and treat up to 25 adult patients with suspected or confirmed pulmonary malignant lesion(s) in patients whom are surgical candidates at 1 clinical site.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patient requires neoadjuvant therapy for the disease for which surgical resection is intended.
- 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.
- Patient is currently enrolled in another interventional clinical trial.
- Patient has a physical or psychological condition that would impair study participation or jeopardize the safety or welfare of the patient.
- Women of childbearing potential who are pregnant, nursing, or planning to get pregnant during their participation in the study.
