NSCLC (Non-small Cell Lung Cancer)NCT07122258
Early Feasibility Study (EFS) of the 'CAROL' for Treatment of Lung Cancer Stage 1
A study testing CAROL NSCLC treatment Device in people with NSCLC (Non-small Cell Lung Cancer), run by Tau Medical Australia Pty Ltd at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- CAROL NSCLC treatment Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Mar 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
- Signed free and informed consent as prescribed by hospital policies.
Who cannot join
- 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
- If the centre of the tumour is not located within the outermost 1/3, exclusion will proceed
- 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
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- 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
- 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)
- 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
- Contraindication to complete neuromuscular blockade during the ablation procedure
- Implantable cardiac devices such as pacemakers or defibrillators, especially with unipolar electrode configurations
- Known hypersensitivity or allergy to gallium, indium, or other components of the conformable electrode
- Medically inoperable conditions
- Participant who is currently participating in, or planning to participate in (during the course of the trial), another non-observational clinical research study
- 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)
- Participant who, in the opinion of the investigator, is not suitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Daniel Steinfort, MD, PhD, +62 407 331 446, Daniel.Steinfort@mh.org.au
About this study
Official title: To Investigate the Safety of the CAROL Device for Lung Tumour Treatment in Patients With Non-small Cell Lung Cancer Tumours(s) ≤ 2 cm (cT1b)
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)
- Being tested
- CAROL NSCLC treatment Device
- Keywords
- CAROL, TAU MEDICAL
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAROL NSCLC treatment DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CAROL NSCLC treatment Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post-procedure
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 5 ~ 10 days after lung resection
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.
Measured: 2~9 days after the CAROL procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-center, open label, single arm, early feasibility study
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tau Medical Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tau-MEDICAL Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122258
- Sponsor's protocol ID
- CAROL
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Safety of the CAROL Device for Lung Tumour Treatment in Patients With Non-small Cell Lung Cancer Tumours(s) ≤ 2 cm (cT1b)
- ClinicalTrials.gov ID
- NCT07122258
- Acronym / sponsor ID
- CAROL
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Keywords
- CAROL, TAU MEDICAL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Tau Medical Australia Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tau-MEDICAL Co., Ltd.
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center, open label, single arm, early feasibility study
| Arm | Type | Receives |
|---|---|---|
| CAROL Device Treatment for Early-Stage NSCLC | Experimental | Device: CAROL NSCLC treatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- 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
- If the centre of the tumour is not located within the outermost 1/3, exclusion will proceed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAROL NSCLC treatment 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. | Device | CAROL Device Treatment for Early-Stage NSCLC |
Primary outcome
Common Terminology Criteria for Adverse Events(CTCAE)
Time frame: 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.
4 secondary outcomes
Device success
Time frame: Immediately after application (measured by imaging during the procedure)
Procedural success
Time frame: Immediately after procedure (intraoperative and early postoperative period)
Procedural success
Time frame: 5 ~ 10 days after lung resection
Procedural success
Time frame: 2~9 days after the CAROL procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAROL NSCLC treatment Device in people with NSCLC (Non-small Cell Lung Cancer), run by Tau Medical Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Steinfort, MD, PhD (+62 407 331 446, Daniel.Steinfort@mh.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common Terminology Criteria for Adverse Events(CTCAE) (time frame: 1 month post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.