NCT07122258

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Tau Medical Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC (Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DEVICE	CAROL 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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2025-08-14
• Last updated: 2026-03-05

Locations

1 site across 1 country: Australia