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

Not Applicable

Not yet recruiting

• Conditions: NSCLC (Non-small Cell Lung Cancer)

• Registration Number: NCT07122258
• Lead Sponsor: Tau-MEDICAL Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-20
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Those who meet all the following criteria are eligible to participate in the clinical trial.

1. Adults 18 years of age or older at the time of screening

2. NSCLC tumour(s)≤ 2 cm (cT1b) suitable for resection

3. Suitable candidate for resection per standard of practice (Lobectomy)

4. NSCLC is confirmed pathologically for the tissue that will be ablated

5. 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

6. Signed free and informed consent as prescribed by hospital policies.

Exclusion Criteria

Those who meet any of the following criteria are excluded from this clinical trial.

1. Centralised tumour (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, oesophagus or trachea)
2. Other primary lung tumours
3. Tumour is associated with vulnerable zone of pleural effusion
4. If the centre of the tumour is not located within the outermost 1/3, exclusion will proceed
5. 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
6. Patients with evidence of severe chronic pulmonary disease including asthma, Chronic Obstructive Pulmonary Disease (COPD), or Interstitial Lung Disease (ILD).
7. Requirement of supplemental oxygen at rest or exercise
8. Hospitalization for cardiac disease within the preceding 3 months
9. Liver enzymes (Alanine Aminotransferase [ALT], Alkaline Phosphatase [ALP], Aspartate Aminotransferase [AST]) or total bilirubin >1.5 upper limit of normal (ULN)
10. Serum creatinine > 2 mg/dl
11. Recent infection (within 30 days)
12. Receiving immunosuppressive medication or prednisone > 20 mg/day (or equivalent)
13. 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
14. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
15. 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
16. 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)
17. 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
18. Contraindication to complete neuromuscular blockade during the ablation procedure
19. Implantable cardiac devices such as pacemakers or defibrillators, especially with unipolar electrode configurations
20. Known hypersensitivity or allergy to gallium, indium, or other components of the conformable electrode
21. Medically inoperable conditions
22. Participant who is currently participating in, or planning to participate in (during the course of the trial), another non-observational clinical research study
23. 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)
24. Participant who, in the opinion of the investigator, is not suitable for participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Common Terminology Criteria for Adverse Events(CTCAE)	1 month post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Device success	Immediately after application (measured by imaging during the procedure)	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	2~9 days after the CAROL procedure	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.