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

Inclusion Criteria11

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.

Exclusion Criteria25

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
Patients with evidence of severe chronic pulmonary disease including asthma, Chronic Obstructive Pulmonary Disease (COPD), or Interstitial Lung Disease (ILD).
Requirement of supplemental oxygen at rest or exercise
Hospitalization for cardiac disease within the preceding 3 months
Liver enzymes (Alanine Aminotransferase \[ALT\], Alkaline Phosphatase \[ALP\], Aspartate Aminotransferase \[AST\]) or total bilirubin \>1.5 upper limit of normal (ULN)
Serum creatinine \> 2 mg/dl
Recent infection (within 30 days)
Receiving immunosuppressive medication or prednisone \> 20 mg/day (or equivalent)
Pre-existing implants - either within the airways or any other location - that impede navigation to or visualisation of the target lesion, in the opinion of the investigator
Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
Disorder of coagulation, history of severe haemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedures and 10 days post-procedures, where this refers to both the ablation and surgical procedures
Any condition or anatomical factor that, in the opinion of the investigator or reviewer, may interfere with the safety of the patient, the conduct of the procedure, or evaluation of the study objectives (e.g. severe bronchial narrowing, wall compromise)
Any tumour characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives
Contraindication to complete neuromuscular blockade during the ablation procedure
Implantable cardiac devices such as pacemakers or defibrillators, especially with unipolar electrode configurations
Known hypersensitivity or allergy to gallium, indium, or other components of the conformable electrode
Medically inoperable conditions
Participant who is currently participating in, or planning to participate in (during the course of the trial), another non-observational clinical research study
Participants who have participated in a non-observational clinical research study within either the past 30 days or who are still within the intervention's wash-out period (whichever is longer)
Participant who, in the opinion of the investigator, is not suitable for participation in the study

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.