This study aims to evaluate the safety of the CAROL device for treating lung tumors in patients diagnosed with non-small cell lung cancer (NSCLC) with tumor size ≤ 2 cm (cT1b). The primary objective is to assess safety by monitoring and grading adverse events using the CTCAE v5.0 criteria at one month following the procedure.
Adults 18 years of age or older at the time of screening
NSCLC tumour(s)≤ 2 cm (cT1b) suitable for resection
Suitable candidate for resection per standard of practice (Lobectomy)
NSCLC is confirmed pathologically for the tissue that will be ablated
Centralised tumour (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, oesophagus or trachea)
Other primary lung tumours
Tumour is associated with vulnerable zone of pleural effusion
If the centre of the tumour is not located within the outermost 1/3, exclusion will proceed
Tau Medical Australia Pty Ltd
Lead sponsor
Tau-MEDICAL Co., Ltd.
Collaborator