Bronchoscopic Microwave Ablation of Lung Tissue

Inclusion Criteria:

The participant may enter the study if ALL of the following apply:

The patient:

1. Has signed the informed consent form

2. Are ≥ 18 years old

3. Has lung lesion(s)/nodule(s) which are histologically confirmed or highly suspiciousfor cancer and is a candidate for bronchoscopic microwave ablation (as determined bya multi-disciplinary team (MDT) or tumour board).

4. Has a medically inoperable soft tissue lung lesion(s) ≤ 20 mm (suspected orconfirmed malignancy), or patient has elected not to have surgery / alternativetherapy.

5. Patient is a candidate for bronchoscopy under general anaesthesia.

6. Subject is willing and able to comply with the study protocol requirements.

7. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or thepatient is deemed fit for general anaesthesia.

Exclusion Criteria:

The participant may not be enrolled in the study if ANY of the following apply:

1. Target nodule(s) are within the International Association for the Study of LungCancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart,oesophagus, spinal cord and phrenic and laryngeal nerves), or are <10 mm from thepleura.

2. Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.

3. Are pregnant or breast feeding, as determined by standard site practices.

4. Have participated in an investigational drug or device research study within 30 daysof enrolment that would interfere with this study.

5. Are scheduled for concurrent interventional procedure for the target soft tissuelesion.

6. Have a physical or psychological condition or other factor(s) that would impairstudy participation, or jeopardise the safety or welfare of the subject.

7. Have an expected survival less than 6 months.

8. Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L.

9. Have an implantable devices, including pacemakers or other electronic implants.

10. Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] > 50mmHg).

11. Who are currently prescribed anticoagulants, clopidogrel or other plateletaggregation inhibitors which cannot be stopped or temporarily withheld.

12. Any patient with clinically significant interstitial lung disease in the zone ofplanned ablation.

13. Patient has nodal disease confirmed through invasive or image-based staging. Note:if nodal disease is suspected or detected during the staging procedure conductedprior to use of the investigational device during the study procedure, the subjectwill be excluded.

14. Subject had a prior pneumonectomy.