RecruitingNAINTERVENTIONAL

An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema

This study is for people with severe emphysema, a lung condition that makes breathing difficult. Researchers are testing a new approach using the AeriSeal System. This system involves putting a special foam into parts of the lung to block what's called 'collateral ventilation.' This step is crucial because it helps make another treatment, called a Zephyr Valve, more effective. The Zephyr Valve is used to reduce the volume of damaged lung, which can improve breathing. The study will enrol about 200 people and follow them for 24 months to see if the AeriSeal foam is safe and if it successfully prepares the lung for the valve treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Pulmonx Corporation

Enrolment target

200

Start

22 Feb 2024

Estimated completion

31 Mar 2028

Emphysema, Pulmonary Emphysema or COPD

What is this study about?

This study is designed for individuals in the UK living with severe emphysema, particularly those whose condition causes significant breathing difficulties. Emphysema is a type of chronic obstructive pulmonary disease (COPD) where the air sacs in the lungs are damaged, making it hard to breathe. The study is exploring a new way to help people who might benefit from a treatment called bronchoscopic lung volume reduction (BLVR), which uses small valves (Zephyr Valves) to close off diseased parts of the lung and allow healthier areas to work better.

The challenge with Zephyr Valves is that they don't work for everyone, especially if there are 'collateral ventilation' pathways in the lung. Imagine your lung is like a house with many rooms; collateral ventilation means there are hidden doorways between rooms that should be separate. If you try to close off one room with a valve, air can still sneak in through these hidden doorways, making the valve less effective. This study introduces the AeriSeal System, a special foam designed to block these hidden pathways before the valves are put in.

So, the main goal of this particular study is to see how well the AeriSeal foam works at sealing these pathways (converting 'collateral ventilation' status). If the foam successfully blocks these pathways, then participants will receive the Zephyr Valve treatment. Researchers will carefully check how people are doing for two years to understand both the safety of the foam and how effective this two-step approach is at improving their breathing.

Key takeaways

This study tests a foam (AeriSeal System) for severe emphysema.
The foam aims to prepare lungs for valve treatment (Zephyr Valve).
It's for people with severe, patchy emphysema.
Participation involves procedures and 2 years of follow-up.
Stopping smoking is a requirement for joining.
The goal is improved breathing for emphysema patients.

Who may be eligible?

To be considered for this study, you'd generally need to be between 40 and 80 years old and have a specific type of severe emphysema that affects only certain parts of your lung, called 'heterogeneous emphysema.' You should also have made an attempt to improve your breathing through a pulmonary rehabilitation programme in the last year.

It's important that you have stopped smoking for at least eight weeks before joining the study. Researchers will also check your lung function and breathing capacity with several tests. These tests will help them understand if the study treatment is suitable for your specific lung condition and if you're healthy enough 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 between 40 and 80 years old?
Have you stopped smoking for at least 8 weeks?
Have you completed recent pulmonary rehabilitation?
Do you have severe emphysema that affects certain parts of your lungs?
Can you walk at least 150 meters (about 164 yards) in six minutes but not more than 450 meters (about 492 yards)?
Do you experience significant breathlessness that impacts your daily life?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll first have several checks to make sure it's right for you. This will include detailed lung scans and breathing tests. If you meet all the requirements, you'll have a procedure under general anaesthetic where a special camera (bronchoscope) is used to confirm the lung pathways are present. Then, the AeriSeal foam will be put into the affected part of your lung.

Around 45 days after the foam treatment, you'll have another check to see if the pathways have been successfully blocked. If they haven't, you might have the foam procedure repeated. Once the pathways are blocked, you'll then have the Zephyr Valve implant procedure in your lung. After this, you'll be followed closely by the study team for two years, attending regular appointments to monitor your progress and well-being. The total duration of active follow-up for the study will be 24 months.

Potential risks and benefits

Participating in this study might offer a potential benefit if the AeriSeal foam prepares your lungs to receive the Zephyr Valve treatment, which could improve your breathing and quality of life. However, as with any medical procedure, there are potential risks, including those associated with anaesthesia, the foam application itself, and the valve placement. These could include discomfort, infection, or other complications. You will be fully informed of all known risks before deciding to participate, and importantly, you have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (36)

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

Banner University Medical Center
Verified postcode
Phoenix, United States· Recruiting
Saint Francis Hospital and Medical Center (Trinity Health of New England)
Verified postcode
Hartford, United States· Recruiting
Orlando Health
Verified postcode
Orlando, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Recruiting
University of Chicago Medical Center
Verified postcode
Chicago, United States· Recruiting
OSF Saint Francis Medical Center
Verified postcode
Peoria, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
Brigham Lung Center
Verified postcode
Boston, United States· Withdrawn
Henry Ford Hospital
Verified postcode
Detroit, United States· Recruiting
Cleveland VA Northeast
Verified postcode
Cleveland, United States· Withdrawn
Penn Medicine
Verified postcode
Philadelphia, United States· Recruiting
Temple University
Verified postcode
Philadelphia, United States· Recruiting

Common questions

What is 'collateral ventilation'?

It's like having hidden air passages within your lungs that bypass the normal airways, making some treatments less effective. The foam aims to seal these.

What is the 'Zephyr Valve' treatment?

It's a procedure where small valves are placed in damaged parts of the lung to reduce their volume, helping healthier parts work better and easing breathing.

Will I have to stop smoking to join?

Yes, you must have stopped smoking for at least eight weeks before you can join this study.

How long will I be followed in the study?

You will be followed by the study team for a total of 24 months, or two years, after your initial treatment.

Is the AeriSeal foam a new treatment?

This study is evaluating the AeriSeal System, meaning it's being carefully tested to understand its safety and effectiveness before it potentially becomes widely available.

How to find out more

Christina Kutzavitch, PhD

ckutzavitch@pulmonx.com +1 650-216-0134 Official trial record

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