Active not recruitingNAINTERVENTIONAL

Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema

This study is a research project looking into a new device called the Apreo Implant for people with severe emphysema, a type of chronic obstructive pulmonary disease (COPD). The main purpose is to see if the implant is safe to use and whether it can help improve symptoms. Researchers also want to find out if it's practical to place the implant. Up to 30 people in Europe and the UK will take part. Participants will have up to two procedures, about a month apart, to place implants in their lungs. They will then have follow-up visits over the next year to check on their progress and well-being. This is an early-stage study to understand how the implant works.

At a glance

Status

Active not recruiting

Phase

Sponsor

Apreo Health, Inc.

Enrolment target

Start

15 Aug 2023

Estimated completion

01 Jun 2026

Emphysema or COPD

What is this study about?

This study is investigating a new treatment called the Apreo Implant for people who have severe emphysema. Emphysema is a lung condition that makes it hard to breathe because the air sacs in your lungs are damaged. Many people with emphysema also have COPD.

The main aim of this study is to answer three important questions: Is this new Apreo Implant safe for people with severe emphysema? Is it practical to put the implant into the lungs? And does it show any early signs of helping people feel better or breathe easier? Because this is a new type of treatment, the study will start with a small number of participants to carefully check for any potential problems.

Researchers hope that if this implant proves to be safe and effective, it could offer a new way to help people with severe emphysema. Finding new ways to manage severe emphysema is very important, as it can significantly affect a person's quality of life.

Key takeaways

This study is for people with severe emphysema or COPD.
It's testing a new device called the Apreo Implant.
The main goals are to check its safety, practicality, and early effectiveness.
Participants will have up to two implant procedures.
Regular follow-up appointments are needed for a year.
It's an early-stage study so benefits are not guaranteed.

Who may be eligible?

To be considered for this study, you would generally need to be between 35 and 80 years old and have a confirmed diagnosis of emphysema or COPD. Doctors will use special scans to check the damage in your lungs and carry out breathing tests to understand how well your lungs are working. You'd also need to experience significantbreathlessness despite your current treatments.

It's important that you have stopped smoking for at least 8 weeks before joining the study and agree not to smoke during your participation. You should also have taken part in a pulmonary rehabilitation programme or been regularly active recently, and be willing to continue. There are certain health conditions or treatments that would mean you couldn't take part. For example, if you have very high blood pressure in your lungs, have had certain lung surgeries in the past, or if you've been hospitalised often for breathing problems recently. Your doctor would help determine if you meet all the criteria.

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 35 and 80 years old?
Do you have severe emphysema or COPD?
Have you quit smoking for at least 8 weeks and plan to stay smoke-free?
Are you able to participate in regular physical activity or pulmonary rehab?
Have you been vaccinated against Covid-19, flu, and pneumonia?
Have you avoided certain lung surgeries in the past?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have up to two procedures, about 30 days apart, to place up to three Apreo implants in each of your lungs. This will involve a medical procedure, and you'll be monitored closely.

After the procedures, you'll need to attend several follow-up appointments. These will be at 30 days, 3 months, 6 months, and 12 months after your final procedure. These appointments are important for the medical team to check on your health, how you're feeling, and how the implants are working. You will not be given any additional medication as part of this study, but you will continue your usual prescribed medications. The total duration of your active participation, including all follow-up visits, will be approximately one year.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new treatment that could improve your breathing and quality of life, although this is not guaranteed as it's an early-stage study. However, like all medical procedures, implanting the Apreo device carries potential risks, including those associated with surgery and the possibility of complications from the device itself. You will have the right to withdraw from the study at any time without needing to give a reason, and it will not affect your usual medical care.

Locations (3)

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

Karl Landsteiner Institute, Klinik Floridsdorf
Verified postcode
Sankt Pölten, Austria
University Medical Center Groningen
Verified postcode
Groningen, Netherlands
Royal Brompton Hospital
Verified postcode
London, United Kingdom

Common questions

What is emphysema?

Emphysema is a lung condition where the air sacs are damaged, making it hard to breathe, especially to exhale air.

What is the Apreo Implant?

The Apreo Implant is a new small device being tested to see if it can help people with severe emphysema breathe better.

How many times will I have a procedure?

You might have up to two procedures, usually about a month apart, to place the implants in your lungs.

How long will I be in the study?

Your involvement will last for about one year, including the procedures and follow-up visits.

Who is paying for this study?

The study is sponsored by a medical device company, likely the developer of the Apreo Implant.