Active not recruitingOBSERVATIONAL

Bronchoscopic Microwave Ablation of Lung Tissue

This research study is testing a new way to treat early lung cancer. It uses a special device called the MicroBlate™ Flex AB1, which works by heating and destroying small growths (nodules) in the lungs. Doctors guide this device into the lung using a procedure called a bronchoscopy. The main goal is to check if this treatment is safe and if it works well for patients. This study is for people with small lung nodules that are suspected to be cancerous or confirmed cancer, especially if surgery isn't an option or they prefer not to have it. Participants will have several check-ups over a year to see how they are doing after the treatment. This is a real-world study, following patients who are already going to have this treatment, to learn more about its effects.

At a glance

Status

Active not recruiting

Sponsor

Creo Medical Limited

Enrolment target

Start

04 May 2023

Estimated completion

01 Dec 2026

Lung Cancer

What is this study about?

This study is about a new approach for treating certain lung cancers. Doctors are looking at a technique called Bronchoscopic Microwave Ablation. This involves using a special, very thin tube (a bronchoscope) that goes into your airways. Through this tube, a tiny device called the MicroBlate™ Flex AB1 is guided to small growths, or 'nodules,' in your lung. This device then uses microwave energy to heat and destroy these nodules.

The main aim of this study is to understand how safe and practical this new treatment is for patients. It's especially useful for people who have small lung nodules that are either suspected to be cancer or are confirmed cancer, and for whom surgery might not be the best option, or who simply prefer not to have surgery. By participating, you'd be helping doctors learn more about this promising treatment so it can potentially help many more people in the future.

This study is designed to watch how things go for patients receiving this treatment in a real-world setting. It will help us understand the short-term and long-term effects, giving doctors a clearer picture of when and how this treatment can be most effective.

Key takeaways

This study evaluates a new microwave treatment for small lung growths.
It aims to see if the treatment is safe and works well for patients.
The treatment involves a bronchoscope to heat and destroy cancer cells.
It's an option for patients where surgery might not be suitable.
Participants will have regular check-ups for a year after the procedure.
Your participation helps doctors learn more about this new treatment.

Who may be eligible?

To join this study, you need to be at least 18 years old and have signed a form saying you understand the study and agree to take part. A team of doctors will need to agree that you have a lung growth (nodule) that is likely or confirmed to be cancer and that this treatment would be suitable for you.

Your lung growth should be 20mm (about the size of a small grape) or smaller, and either surgery isn't possible for you, or you've decided against it. You also need to be well enough to have a general anaesthetic for the procedure and be willing to come for all the follow-up appointments.

There are also reasons why you might not be able to join. For example, if your lung growth is too close to important body parts like your heart or major blood vessels, or if you are pregnant or breastfeeding. You would also not be able to join if you are already taking part in another drug or device study that might affect this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a lung growth that doctors think might be cancer or is confirmed cancer?
Is your lung growth suitable for this heating treatment and not too large?
Are you able to have a general anaesthetic?
Are you willing and able to attend all the follow-up appointments?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a meeting where the study is fully explained, and you'll sign a consent form. Then, you'll have a check-up to make sure you're suitable for the study. If you are, you'll have another assessment before the procedure itself.

The main part involves the bronchoscopic microwave ablation treatment. After the procedure, you'll have a check-up, and then a series of follow-up visits. These include a phone call or in-person visit around 1 week later, and then further visits at 1 to 1.5 months, 3 months, 6 months, 9 months, and 12 months after your treatment. You won't be taking any special medication as part of this study; it's about the procedure itself and your recovery.

Potential risks and benefits

Potential benefits of taking part include receiving a new, potentially less invasive treatment for your lung nodule, which might be especially helpful if surgery isn't an option for you. However, as with any medical procedure, there are potential risks, such as side effects from the general anaesthetic, or complications related to the bronchoscopy or the ablation itself. These will be fully explained to you before you agree to take part. Remember, joining the study is entirely your choice, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
Verified postcode
Amsterdam, Netherlands
Royal Brompton and Harefield NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is a 'lung nodule'?

A lung nodule is a small, round growth in the lung that can be seen on scans. It might be harmless, or it could be cancer.

What is a 'bronchoscopy'?

A bronchoscopy is a procedure where a thin, flexible tube with a camera is passed through your nose or mouth into your airways to look at your lungs.

What does 'ablation' mean?

Ablation means to remove or destroy tissue, in this case, using heat from microwaves to treat the lung nodule.

Will I have general anaesthesia?

Yes, you will have a general anaesthetic for the procedure, meaning you will be asleep during the treatment.

How long will I be followed after the treatment?

You will be followed up for a total of 12 months (one year) after your treatment, with several check-ups during that time.