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

NCT07122258 | Recruiting DMC

• 1 other identifier: CAROL
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC (Non-small Cell Lung Cancer)

Keywords

CAROL; TAU MEDICAL

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month post-procedure

Secondary Outcomes (4)

• Device success

  Immediately after application (measured by imaging during the procedure)

• Procedural success

  Immediately after procedure (intraoperative and early postoperative period)

• Procedural success

  5 ~ 10 days after lung resection

• Procedural success

  2~9 days after the CAROL procedure

Other Outcomes (8)

• Evaluation of Quality of Life scores

  2~9 days after CAROL the procedure

• Evaluation of pain scores

  2~9 days after the CAROL procedure

• Predicted and actual volume of liquid metal delivered

  6~14 days after the CAROL procedure

Study Arms (1)

CAROL Device Treatment for Early-Stage NSCLC

EXPERIMENTAL

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.

Device: CAROL NSCLC treatment Device

Interventions

CAROL NSCLC treatment Device 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.

CAROL Device Treatment for Early-Stage NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tau Medical Australia Pty Ltd: lead
• Tau-MEDICAL Co., Ltd.: collaborator

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Daniel Steinfort, MD, PhD

CONTACT

+62 407 331 446; Daniel.Steinfort@mh.org.au

Jaeyoung Seo

CONTACT

+82 10 4844 3203; sjy@tau-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, open label, single arm, early feasibility study

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 14, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

AU (1)