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New device aims to zap small lung tumors before surgery

NCT ID NCT07122258

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing the safety of a new device called CAROL for treating small lung tumors (≤2 cm) in people with non-small cell lung cancer. Seven participants will receive a single treatment with the device, followed by surgical removal of the tumor. The main goal is to see if the device is safe and to check for any side effects within the first month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CAROL device (a conformable electrode for tumor ablation)
What this could lead to
If successful, this could lead to a less invasive treatment option for small lung tumors, potentially reducing the need for more extensive surgery.
What could go wrong
This is a very early, small safety study with only 7 participants. The device may not work as intended, and risks include side effects from the procedure. It is not yet proven to be effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 7 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, 3050, Australia

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Other studies related to the condition(s) this trial covers.