Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.
This study is investigating a new treatment for lung cancer called the FlexAblate™ Microwave Ablation System. It aims to find out how well this system treats cancerous nodules in the lung and to check its safety. It's open to adults aged 18 and over who have been diagnosed with lung cancer, either primary or secondary, and are considered unsuitable for surgery, or have chosen not to have surgery. If you meet the criteria, you would receive the microwave ablation treatment and then have follow-up appointments over 12 months, including CT scans and health checks. This research is important to understand if this new technology offers a safe and effective option for patients.
At a glance
What is this study about?
This clinical study is designed to explore a new way of treating lung cancer, specifically cancerous growths (nodules) in the lung. The treatment method being investigated is called microwave ablation, using a device known as the FlexAblate™ Microwave Ablation System. This treatment uses heat, generated by microwaves, to destroy cancer cells in the lung.
The main goal of this study is twofold: first, to see how effectively the FlexAblate™ system treats these lung nodules, meaning if it can successfully reduce or eliminate the cancerous cells. Second, and equally important, the study aims to understand the safety of this treatment. Researchers want to ensure that any potential side effects are manageable and that the procedure is generally well-tolerated by patients.
This research is particularly relevant for individuals with lung cancer who might not be able to have surgery, or who have decided against surgery as a treatment option. By participating, you would be helping medical professionals understand if this microwave ablation system offers a valuable and safe alternative for treating lung cancer.
Key takeaways
- Investigating a new microwave treatment for lung cancer nodules.
- For patients who cannot have surgery or choose not to.
- Aims to check both effectiveness and safety of the treatment.
- Participation involves treatment and follow-up appointments for one year.
- Includes CT scans and health checks after the procedure.
Who may be eligible?
This study is looking for adults aged 18 or over. You would need to have a confirmed cancerous nodule in your lung, which could be a primary lung cancer or cancer that has spread from another part of your body. The nodule shouldn't be larger than 20mm, and there needs to be enough clear lung tissue around it.
Crucially, you would be considered if surgery isn't suitable for you, or if you have chosen not to have surgery. You wouldn't be able to join if the nodule is too close to major airways, blood vessels, or other vital organs like the heart or gullet. Also, people with severe breathing difficulties, certain blood clotting problems, or those who are pregnant or breastfeeding would not be able to take part.
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 confirmed cancerous nodule in your lung?
- Is your lung nodule 2cm or smaller?
- Are you unable to have surgery for your lung cancer, or have you decided against it?
- Are you generally well enough to have a medical procedure?
What does participation involve?
If you join this study, your journey would begin with a screening assessment. This involves reviewing your medical history, current medications, a blood test, and assessing your quality of life. This helps the study team confirm if the treatment is right for you. If you meet all the criteria, you would then undergo the microwave ablation procedure using the FlexAblate™ system.
After the treatment, you'll have several follow-up appointments. These are scheduled at one week, and then at one, three, six, and twelve months after your procedure. During these visits, you'll typically have CT scans (a special type of X-ray), blood tests, and check-ups on your overall health and quality of life. The total duration of your active participation, including screening and all follow-up appointments, would be about 12 months.
Potential risks and benefits
Locations (3)
- CMC Ambroise Paré - HartmannVerified postcodeParis, France· Recruiting
- St. Bartholomew's HospitalVerified postcodeLondon, United Kingdom· Recruiting
- University College London Hospitals NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is microwave ablation?
Microwave ablation is a procedure that uses heat, generated by microwaves, to destroy cancer cells in your lung.
Who can join this study?
Adults aged 18 or over with a confirmed cancerous lung nodule, who can't have surgery or choose not to, might be eligible.
What kind of lung cancer is eligible?
The study is for primary lung cancer or cancer that has spread to the lung from another part of the body.
How long does the study last?
If you join, your participation would involve a screening, the treatment, and follow-up appointments for about 12 months.
Will I have regular check-ups?
Yes, you would have follow-up appointments at 1 week, and then at 1, 3, 6, and 12 months after your treatment.
How to find out more
Annette Kent, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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