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RECRUITING
NCT07122258
NA

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

Sponsor: Tau Medical Australia Pty Ltd

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2026-03-01

Completion Date

2027-06-01

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

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.

Locations (1)

Royal Melbourne Hospital

Melbourne, Victoria, Australia