Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.

This is a prospective, single-arm, non-randomised clinical investigation. Up to 43 subjects will be enrolled from up to 5 sites. The clinical investigation is designed to evaluate the performance and safety of the Endowave FlexAblate™ Microwave Ablation System device in subjects undergoing lung ablation procedures. Microwave Ablation System device in subjects undergoing lung ablation procedures.

Inclusion criteria

• Adult ≥ 18 years of age who has provided signed informed consent.
• Subject is able and willing to comply with the planned clinical investigation follow-up schedule
• Pathological confirmed malignant nodule in the lung either primary or metastatic disease.
• Target nodule is ≤ 20mm in maximum diameter.
• There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure.
• Subject is a candidate for an elective lung ablation procedure as determined by institutional multi-disciplinary board or equivalent.
• Subject or the lesion is not suitable for surgery or patient refuses surgery.

Exclusion criteria

• Target nodule is abutting main or lobar stem bronchus, main pulmonary vasculature (vessel 5mm), heart, oesophagus and/or trachea.
• Subjects who are extremely breathless or on home oxygen therapy.
• Female subjects who are pregnant or nursing.
• Subjects with uncorrectable coagulopathy or thrombocytopenia at time of screening.
• Subjects with prior pneumonectomy.
• Subjects who have had any radiation (i.e., SBRT or EBRT) to the intended ablation zone or lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation).
• Subjects who have implantable electronic devices, including pacemakers or other electronic implants.
• Known pulmonary hypertension (Pulmonary artery systolic pressure, PASP >50mmHg).
• Active active pulmonary infection at time of screening or the procedure.
• Subjects medically unable to stop anticoagulant or anti-platelet therapy for relevant time period prior to and following the ablation procedure.
• Participation in an investigational drug or device clinical investigation within 30 days of enrolment that would interfere with this clinical investigation.
• The investigator determines that participation in this clinical investigation may jeopardise the safety or welfare of the subject.