Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.
∙ 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.