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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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.
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.
Time frame: 1 month post-procedure
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.
Time frame: Immediately after application (measured by imaging during the procedure)
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
Time frame: Immediately after procedure (intraoperative and early postoperative period)
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.
Time frame: 5 ~ 10 days after lung resection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 2~9 days after the CAROL procedure