Active not recruitingNAINTERVENTIONAL

Ryme Medical TLD Pilot Study

This study focuses on a new treatment called Targeted Lung Denervation (TLD) for chronic obstructive pulmonary disease (COPD). COPD is a long-term lung condition that makes it hard to breathe. The study is trying out a specific TLD system made by Ryme Medical. Its main goal is to check if this new treatment is safe and if it helps people with COPD. This is an early-stage study, meaning it's one of the first times this treatment is being looked at in detail. Researchers will be observing how the system works and gathering important information to decide if it could be a good option for future treatment of COPD. They are inviting people with COPD to participate across different medical centers.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ryme Medical, Inc.

Enrolment target

Start

06 Mar 2024

Estimated completion

01 May 2026

Chronic Obstructive Pulmonary Disease

What is this study about?

This study is about a new way to treat Chronic Obstructive Pulmonary Disease, often shortened to COPD. COPD is a common lung condition that makes it difficult to breathe because the airways in your lungs are narrowed and damaged. It can cause symptoms like shortness of breath, coughing, and wheezing. This research is investigating a treatment called Targeted Lung Denervation, or TLD for short. Think of it like this: in COPD, certain nerves in the lungs can make breathing harder. TLD aims to gently adjust these nerves to help open up your airways, making it easier to breathe.

The researchers are specifically using a device from a company called Ryme Medical. They want to carefully check if using this Ryme Medical TLD system is safe for people with COPD. They also want to see if it actually helps improve breathing and overall well-being. This is an important step because if the treatment proves to be safe and effective in this early study, it could eventually become a new option for people living with COPD.

This is a 'pilot study,' which means it's one of the first studies to look closely at this particular treatment in people. It’s not a large, full-scale study yet, but rather a smaller one designed to gather important information. The results from this pilot study will help doctors and researchers understand more about TLD and decide if further, larger studies are needed. The ultimate goal is to find better ways to help people manage their COPD and improve their quality of life.

Key takeaways

The study explores a new COPD treatment called Targeted Lung Denervation (TLD).
It aims to check if the Ryme Medical TLD system is safe and works well.
Participation requires you to be at least 40 years old with symptomatic COPD and a smoking history.
You cannot join if you currently smoke, use e-cigarettes, or have certain other medical conditions.
Taking part means undergoing the TLD procedure and attending follow-up appointments.
There are potential benefits and risks, which will be fully discussed with you.

Who may be eligible?

To join this study, you need to have a chronic obstructive pulmonary disease (COPD) that causes symptoms. You also need to be at least 40 years old and have a history of smoking for at least 10 'pack years' (this is a way doctors measure how much someone has smoked over time). Importantly, a doctor involved in the study must believe that you would be a suitable candidate for a procedure called a bronchoscopy.

However, there are certain reasons why you wouldn't be able to join. For example, if you've recently had a flare-up of your COPD or a lung infection, or if you've had lung surgery where a device was left in place. You also can't participate if you have certain other serious health issues like an untreated growth in your lung, active cancer treatment, or uncontrolled diabetes or heart problems.

Finally, if you currently smoke, use e-cigarettes, vape, or use other inhaled substances not prescribed by a doctor, you won't be able to join. The study also cannot include women who are pregnant, breastfeeding, or planning to become pregnant during the study period, as the safety for them and their babies is unknown.

Quick self-check

Do you have COPD symptoms?
Are you 40 years old or older?
Have you smoked for at least 10 'pack-years' in your lifetime?
Are you NOT currently smoking, vaping, or using e-cigarettes?
Have you NOT had a recent COPD flare-up or lung infection?
Are you NOT pregnant or breastfeeding, and not planning to become pregnant during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will undergo a procedure called Targeted Lung Denervation (TLD) using the Ryme Medical system. The study aims to evaluate the safety and performance of this system, so you will have several assessments before, during, and after the procedure. These assessments will likely include lung function tests, questionnaires about your symptoms and quality of life, and possibly imaging scans like X-rays or CT scans to monitor your lungs.

While the exact schedule isn't detailed, typical studies like this involve an initial screening visit to confirm you're eligible, the TLD procedure itself, and then several follow-up visits over a period of time. These follow-up visits will be to check your recovery, monitor for any side effects, and see how your COPD symptoms are responding to the treatment. You will not be given any new study medication to take at home, as the intervention is a procedure. The total duration of your participation could range from several months to a year or more, depending on the follow-up schedule required to fully assess the treatment's impact.

Potential risks and benefits

Taking part in this study might offer a potential benefit by giving you access to a new treatment for your COPD that isn't widely available yet, which could potentially improve your breathing and quality of life. However, like any medical procedure, there are potential risks, including those associated with a bronchoscopy and the TLD treatment itself. These could include discomfort, infection, bleeding, or other unforeseen complications associated with interfering with lung nerves. All risks will be fully explained to you before you agree to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Melbourne Health - The Royal Melbourne Hospital
Melbourne, Australia
Macquarie University
Sydney, Australia
Karl Landsteiner Institute for Lung Research
Vienna, Austria
Rigshospitalet
Copenhagen, Denmark
Healthycore
Tbilisi, Georgia
University of Groningen Medical Center
Groningen, Netherlands
Royal Brompton
London, United Kingdom

Common questions

What is COPD?

COPD, or Chronic Obstructive Pulmonary Disease, is a common lung condition that makes it hard to breathe due to damaged and narrowed airways in your lungs.

What is Targeted Lung Denervation (TLD)?

TLD is a new treatment being studied for COPD. It aims to gently adjust certain nerves in your lungs that might be making it harder to breathe, potentially helping to open up your airways.

Is this treatment available to everyone with COPD?

No, this is a pilot study, meaning it's an early investigation. The treatment is only available to eligible participants within the study. It's not yet a standard treatment for COPD.

What will happen if I join the study?

If you join, you will receive the TLD procedure. Doctors will then check your health, breathing, and symptoms through several visits and tests over a period of time to see how you are doing.

Can I leave the study if I change my mind?

Yes, your participation is entirely voluntary. You can choose to leave the study at any time, for any reason, without it affecting your regular medical care.