NCT07122258
Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1
Recruiting · Not Applicable · Tau Medical Australia Pty Ltd · registry updated 2026-03-05
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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:
Exclusion
- Those who meet any of the following criteria are excluded from this clinical trial.
- 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
- PFT: post-bronchodilator forced expired volume in on second (FEV1) or forced vital capacity (FVC) ≤60% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 50% predicted