A Clinical Investigation in lUng canceR of the Endowave FlexAblate™ Microwave tRansbronchial Ablation System.
The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system. Participants in this clinical trial will be patients aged over 18 years who have been previously diagnosed with cancer in the lung (primary or secondary malignant tumours) and deemed unsuitable for surgery or are declining surgery or, patients suitable for microwave ablation procedure based on clinical assessment. Those who meet all of the eligibility criteria at a screening assessment (a review of eligibility to participate in the study includes review of information on the cancerous nodule, recording your medical history, current medications, a blood test, and quality of life assessments) will undergo the ablation treatment with FlexAblate™ Microwave Ablation System. Follow-up assessments will be at week 1 and months 1, 3, 6 and 12 will includes CT Scans (CT or CAT scan is a computed tomography scan), blood tests, assessment of overall health and quality of life assessments.
• 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.