Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

This is a post-market, prospective, single-arm, multicentre, open-label, non-randomised study which will enrol up to 30 subjects in total (plus replacements if required due to drop out).

Prospective patients must have a histopathological-confirmed malignant lung lesion and be candidates for surgical resection. After being informed about the study and potential risks, all patients giving their written informed consent will undergo a screening visit to determine eligibility for study entry.

The study consists of two (2) stages (Stage A and Stage B). Stage A consists of the ablation and surgical resection being performed concurrently on Day 0 within a single procedure. Stage B consists of the ablation and the surgical resection being performed in separate procedures. The surgical resection will occur between Day 7 and Day 21, post-ablation, inclusive of those days. The aim is to follow local guidelines for treatment of lung cancer.

Patients undergoing Stage A will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Patients undergoing Stage B will have evaluations at follow-up visits conducted at 7 (+/-3) days (via phone call) post ablation and prior to the surgical resection procedure. Stage B patients will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Inclusion criteria

Patients who:

• Have signed informed consent.
• Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
• Are ≥ 18 years old.
• Have lung lesion(s)/nodule(s) which are histopathological-confirmed as cancer.
• Have soft tissue lung lesion(s):

• ≤ 30 mm in the largest dimension of the pulmonary window for Stage A.
• ≤ 20 mm in the largest dimension of the pulmonary window for Stage B.
• Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
• Greater than 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
• Subject is willing and able to comply with the study protocol requirements.
• Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion criteria

Patients who:

• Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic & laryngeal nerves).
• Are pregnant or breast feeding, as determined by standard site practices.
• Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
• Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
• Have an expected survival less than 12 months.
• Have bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10^9/L.
• Have an implantable device, including pacemakers or other electronic implants.
• Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
• Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.
• Subject had a prior pneumonectomy.
• Diagnosis of Small Cell Lung Cancer.
• Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
• Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
• Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.