Actively Recruiting
Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1
Led by Tau Medical Australia Pty Ltd · Updated on 2026-03-05
7
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
T
Tau Medical Australia Pty Ltd
Lead Sponsor
T
Tau-MEDICAL Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of screening
- Non-small cell lung cancer tumors 2 cm or smaller (cT1b) suitable for surgical removal
- Candidate for lobectomy surgery according to standard practice
- Pathological confirmation of NSCLC in the tissue to be treated
- Tumor located in the outer one-third of the lung allowing complete tumor removal by lobectomy and ablation
- Signed informed consent according to hospital policies
You will not qualify if you...
- Tumor located centrally in the inner one-third of the lung not suitable for resection
- Presence of other primary lung tumors
- Tumor associated with pleural effusion in a vulnerable zone
- Post-bronchodilator lung function (FEV1 or FVC) less than 60% predicted or DLCO less than 50% predicted
- Severe chronic pulmonary diseases including asthma, COPD, or interstitial lung disease
- Need for supplemental oxygen at rest or during exercise
- Hospitalization for cardiac disease within the prior 3 months
- Elevated liver enzymes or total bilirubin greater than 1.5 times the upper limit of normal
- Serum creatinine above 2 mg/dl
- Recent infection within 30 days
- Use of immunosuppressive medication or prednisone over 20 mg/day
- Presence of implants that block navigation or visualization of the tumor
- Pregnant or breastfeeding, or not using reliable contraception if of childbearing potential
- Blood clotting disorders, history of severe bleeding, or use of anticoagulant medication (antiplatelet medication allowed if held as specified)
- Any condition or anatomical factor that may compromise patient safety or study evaluation
- Contraindication to neuromuscular blockade during the procedure
- Presence of implantable cardiac devices like pacemakers or defibrillators with unipolar electrodes
- Known allergy to gallium, indium, or components of the electrode
- Medically inoperable conditions
- Current or planned participation in another interventional clinical research study
- Participation in another interventional study within the past 30 days or during the wash-out period
- Investigator judgment deeming participant unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Actively Recruiting
Research Team
D
Daniel Steinfort, MD, PhD
CONTACT
J
Jaeyoung Seo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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