Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation.

There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital.

Participation in this study has the potential to provide the following benefits for other people who have the same medical condition:

• The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure.
• Shorter patient recovery times.
• Reduced incidence of complications.

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):

• ≤ 20 mm in the largest dimension of the pulmonary window
• Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
• > 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 an implantable device, including pacemakers or other electronic implants.
• Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
• Subject had a prior pneumonectomy.
• Diagnosis of Small Cell Lung Cancer.
• 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.