RecruitingNot ApplicableNCT07122258

Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1

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)

Sponsor

Tau Medical Australia Pty Ltd

Enrollment

7 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

NSCLC (Non-small Cell Lung Cancer)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early feasibility study is testing a new device called 'CAROL' designed to treat early-stage lung cancer (non-small cell lung cancer, NSCLC) as an alternative or addition to surgery. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with early-stage non-small cell lung cancer (NSCLC) with a tumor 2 cm or smaller - Your doctors have determined you are a suitable candidate for surgery **You may NOT be eligible if...** - Your tumor is larger than 2 cm or more advanced - You are not considered a surgical candidate by your medical team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECAROL NSCLC treatment Device

Participants in this single-arm study will undergo treatment with the CAROL device for localized lung tumors (NSCLC ≤ 2 cm, cT1b). All participants will receive a single CAROL procedure using a conformable electrode, followed by surgical resection of the tumor. The first 3 sentinel participants will receive a maximum dose of 0.3 mL of the conformable electrode. The next 4 participants will receive up to 2.0 mL. Safety and preliminary efficacy will be assessed through scheduled follow-up visits, including imaging, pulmonary function testing, laboratory assessments and pain monitoring. Adverse events will be monitored throughout the study, with grading based on CTCAE v5.0, specifically focusing on "Respiratory, thoracic, and mediastinal disorders." The study includes visits at screening, pre-procedure, post-procedure (24-36 hours), pre- and post-resection, and follow-up at approximately one and three months.