To Investigate the Safety of the CAROL Device for Lung Tumour Treatment in Patients With Non-small Cell Lung Cancer Tumours(s) ≤ 2 cm (cT1b)
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.
∙ Those who meet all the following criteria are eligible to participate in the clinical trial.
• 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
• Location of tumour:
‣ ① in outer one thirds of lung (between outermost 1/3 measured by tumour centre),
⁃ ② if the centre of the tumour is located within the outermost 1/3, inclusion will proceed,
⁃ ③ anticipation that resection (lobectomy) would remove all gross tumour and ablation with grossly negative margins,
⁃ ④ one or more radiofrequency ablation (RFA) applications would target entire margin according to the RFA plan
• Signed free and informed consent as prescribed by hospital policies.