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.
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
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
Single group
CAROL NSCLC treatment Device
DeviceParticipants 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.
Common Terminology Criteria for Adverse Events(CTCAE)
Graded using CTCAE grade (v5.0) criteria(CTCAE) The CTCAE utilizes a scale ranging from Grade 1 (mild) to Grade 5 (death-related) to classify the severity of adverse events. A higher CTCAE grade indicates increased severity of the adverse event, signifying a worse outcome.
Device success
Success rate of CAROL device positioning at the target site The success rate of CAROL device positioning at the target site immediately after application, as assessed by fluoroscopic imaging and /or bronchoscopic visualization during the procedure. Proper positioning is defined as complete coverage of the target segmental bronchus by the ablation electrode without malposition or dislodgement. Frequencies and percentages will be presented to summarise the success rate.
Procedural success
Successful delivery of the ablation treatment for lung cancer using the CAROL system, performed according to the Instruction for Use (IFU) and treatment plan. Success will be determined based on the following criteria: Successful delivery of the CAROL catheter to the target site Successful injection of the Conformable Electrode (E-GaIn) Achievement of target ablation temperature Retrieval of the device without malfunction
Procedural success
Pathological analysis Pathological evidence of effective ablation will be evaluated using hematoxylin and eosin (H\&E) staining to assess tissue viability. The extent of the coagulative necrotic zone relative to the tumor location will be quantified by pathologists. Descriptive statistics (mean, range) will summarize the extent of ablation effectiveness.
Procedural success
Imaging data evaluation Imaging data from computed tomography (CT) scans will be assessed to evaluate the extent of ablation, including lesion size and ablation margin relative to baseline. Measurements will be reviewed by radiologists using standard radiologic assessment criteria. Descriptive statistics will be presented for changes in treated areas.
Evaluation of Quality of Life scores
Evaluation of Quality of Life scores(EQ-5D) The EQ-5D questionnaire will be used to assess patient's health-related quality of life. The EQ-5D includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on 5 levels. Scores will be converted to an index value ranging from -0.594 (worst health state) to 1.000 (perfect health), based on country-specific value sets. Higher scores indicate better health-related quality of life.
Evaluation of pain scores
Visual Analogue Scale (VAS) Pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated instrument consisting of a 10 cm horizontal line anchored by "no pain" (0) and "worst imaginable pain" (10). Participants will be asked to indicate their current level of pain on the scale. Higher scores indicate greater pain severity.
Predicted and actual volume of liquid metal delivered
The volume of Conformable Electrode (E-GaIn) predicted during the planning phase will be compared with the actual volume delivered during the CAROL procedure. Measurements will be obtained from procedure records and delivery system readouts. Differences will be quantified in milliliters (mL) and summarized using descriptive statistics.
Predicted and actual ablation size
The ablation size predicted during pre-treatment planning will be compared to the actual ablation zone measured by post-procedural imaging. Ablation volume will be quantified in cubic centimeters (cm3) using CT or MRI data, and descriptive statistics will be used to summarize differences.
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Tau Medical Australia Pty Ltd
Lead sponsor
Tau-MEDICAL Co., Ltd.
Collaborator
