A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
This research is looking at a new device called the IAB 50 Flex, which is an implantable artificial bronchus. It's being tested in people in the UK who have severe emphysema, a long-term lung condition that makes it hard to breathe. The study aims to find out if this new implant is safe and if it can help improve breathing and quality of life for those with severe emphysema. Two hospitals are involved in this trial, which is for adults aged 22 and over. It's an important step in finding new ways to help people living with this challenging lung disease.
At a glance
What is this study about?
Imagine your lungs are like a tree with many branches, getting smaller and smaller, carrying air to tiny sacs where oxygen goes into your blood. Emphysema is a condition that damages these tiny air sacs and the small airways, making it really hard for your lungs to work properly and get enough oxygen. This can leave you feeling breathless, tired, and limit what you can do.
Doctors are always looking for better ways to help people with severe emphysema. This study is testing a new device called the IAB 50 Flex. Think of it as a small, flexible tube that's designed to be placed inside your lung to help improve how air moves by supporting the damaged airways. The aim is to see if this implant can make breathing easier and ultimately improve your daily life.
This research is being carried out in two hospitals and will carefully check both the safety of the implant and how well it works. By taking part in studies like this, patients help doctors learn more about new treatments, which could eventually benefit many others living with similar lung conditions.
Key takeaways
- Tests a new implant (IAB 50 Flex) for severe emphysema.
- Aims to improve breathing and quality of life.
- Involves a surgical procedure to place the implant.
- Requires regular hospital visits for check-ups.
- It's a research study to find new treatment options.
- Participation is voluntary and you can withdraw anytime.
Who may be eligible?
To join this study, you need to be at least 22 years old and have been diagnosed with emphysema or severe COPD. You also need to have stopped smoking, including e-cigarettes and cannabis, for at least four months before being considered. Your emphysema should be stable, and you should be able to walk a certain distance within six minutes.
There are also some reasons why you might not be able to join. For example, if you're already in another study involving surgery or new medicines, or if you've had certain lung surgeries in the past. Women who could become pregnant also can't take part. They'll also check for other health conditions like severe heart problems, uncontrolled high blood pressure in your lungs, or certain types of infections which would mean you can't join.
Another important point is that if you've had frequent chest infections requiring hospital stays recently, or if you have a lot of mucus production, you might not be eligible. If you take blood thinners, you'd need to be able to safely stop them for a short time for the procedure.
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 at least 22 years old?
- Have you been diagnosed with severe emphysema or COPD?
- Have you stopped smoking (including vaping/cannabis) for at least 4 months?
- Are you able to walk between 100-400 metres in 6 minutes?
- Are you able to pause taking blood thinning medication if needed?
- Have you *not* had frequent hospital stays for lung infections recently?
What does participation involve?
If you decide to take part, you would first have a number of health checks and scans to make sure this study is right for you. If you qualify, you would undergo a procedure to have the IAB 50 Flex implant placed in your lung. This is a surgical procedure. After the implant, you would have regular follow-up visits to the hospital. These visits would involve check-ups, breathing tests, and possibly more scans to see how you are doing and how the implant is working. You would also be asked about your general health and how you feel. The total duration of your participation in the study, including follow-up, would be discussed with you, but it would involve regular commitment over an extended period.
Potential risks and benefits
Locations (2)
- DUPUYTREN University HospitalVerified postcodeLimoges, France· Recruiting
- University Medical Center GroningenVerified postcodeGroningen, Netherlands· Recruiting
Common questions
What is emphysema?
Emphysema is a lung condition where the air sacs in your lungs are damaged, making it hard to breathe and get enough oxygen.
What is the IAB 50 Flex?
It's a new, flexible tube designed to be implanted in the lung to help improve airflow for people with severe emphysema.
Will I need surgery?
Yes, if you're eligible and choose to participate, a surgical procedure would be needed to place the implant in your lung.
How long does the study last?
The study involves regular check-ups and follow-up after the implant, over an extended period, which the doctors will explain in more detail.
Can I stop participating if I want to?
Yes, you are completely free to withdraw from the study at any time, and it won't affect your normal medical care.
How to find out more
VP Clinical Operations
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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