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RecruitingNAINTERVENTIONAL

The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema

This study, called 'The REDUCE EU Study', is investigating a new treatment for severe emphysema. Emphysema is a lung condition that makes it hard to breathe. The treatment, called Endobronchial Thermal Liquid Ablation (ETLA), involves a procedure to reduce the size of over-inflated areas in the lungs. Doctors hope this will help patients breathe more easily and feel better. The main goal is to check how safe and practical ETLA is. Later, they will also look at how well it works. Participants will have one or two ETLA procedures and will complete several follow-up appointments, both in person and online.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Morair Medtech, LLC
Enrolment target
30
Start
10 Jan 2025
Estimated completion
01 May 2026

What is this study about?

This study is looking into a new treatment called Endobronchial Thermal Liquid Ablation, or ETLA for short. It's designed for people who have severe emphysema, a condition where the air sacs in your lungs get damaged and make it difficult to breathe.

Traditional treatments for emphysema usually involve medicines to help manage symptoms. This new ETLA treatment aims to actually shrink parts of the lung that are overinflated and not working properly. By doing this, the hope is to make more space for healthier parts of your lungs to work better, which could help you breathe more easily and improve your overall quality of life.

The main purpose of this study is to first check if the ETLA procedure is safe for patients and if it can be done successfully. Once they understand the safety and practicality, they will then look at whether it actually helps people with their breathing and how they feel day-to-day. This is an important step in finding new and better ways to help people living with severe emphysema.

Key takeaways

  • This study is testing a new treatment called ETLA for severe emphysema.
  • The main goals are to check if ETLA is safe and practical, then to see how well it works.
  • Participants may have one or two ETLA procedures.
  • There will be follow-up appointments, both in person and online.
  • This could be a new way to help people breathe easier and improve their quality of life.
  • Joining a study is always your choice, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a clear diagnosis of COPD with severe emphysema. Your lung function tests will need to show specific details about how well your lungs are working. You should also be able to walk a certain distance in six minutes and experience some breathlessness in your daily life. It's important that your emphysema is being managed well with medications, and you must not have smoked for at least three months before joining. Keeping active is also key, as you need to be regularly exercising and willing to continue throughout the study.

There are also some things that would mean you can't join. For example, if you are very underweight or very overweight (your BMI needs to be within a certain range). You also can't have other serious lung conditions like chronic bronchitis with a lot of mucus, or a history of frequent hospital stays for your COPD. Also, severe asthma would prevent you from taking part. You'll need to live close enough to the study hospital or be able to stay there for a few days after 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.

  1. Are you 40 years old or older?
  2. Do you have severe emphysema?
  3. Have you not smoked for at least 3 months?
  4. Do you exercise regularly?
  5. Is your weight within a healthy range?
  6. Are you able to get to the study hospital easily?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might have one or two ETLA procedures. After each procedure, you will have several appointments to check on your progress and make sure you are doing well. Some of these appointments will be in person at the clinic, while others can be done virtually from your home. The research team will carefully monitor your health throughout the study to make sure everything is going as planned.

Potential risks and benefits

Participating in a study like this might offer some potential benefits, such as access to a new treatment that could help improve your breathing and quality of life if it proves to be effective. However, as with any medical procedure, there are potential risks involved, which the study team will explain in detail, including possible side effects or complications from the ETLA treatment. You will be given all the information to make an informed decision, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (7)

  • Universitätsklinikum Allgemeines Krankenhaus Wien
    Verified postcode
    Vienna, Austria· Not yet recruiting
  • Klinik Floridsdorf
    Verified postcode
    Vienna, Austria· Recruiting
  • Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
    Verified postcode
    Berlin, Germany· Recruiting
  • Asklepios Lungenklinik Gauting GmbH
    Verified postcode
    Gauting, Germany· Not yet recruiting
  • Asklepios Klinik Barmbek
    Verified postcode
    Hamburg, Germany· Not yet recruiting
  • Thoraxklinik University of Heidelberg
    Verified postcode
    Heidelberg, Germany· Not yet recruiting
  • University Medical Center Groningen
    Verified postcode
    Groningen, Netherlands· Not yet recruiting

Common questions

What is emphysema?

Emphysema is a lung condition that damages the air sacs in your lungs, making it harder to breathe and get enough oxygen.

What is ETLA?

ETLA is a new treatment being studied where doctors try to shrink overinflated parts of your lungs to help you breathe better.

Will I need surgery for ETLA?

The ETLA procedure is done using a thin tube inserted into your lungs, which is usually less invasive than open surgery.

How long will the study last?

The study involves up to two procedures and several follow-up visits, both in person and virtual. The team will give you a clear timeline.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "The REDUCE EU Study - Endobronchial Thermal Liquid Ablation …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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