About this trial
The goal of this study is to test whether a new treatment called the Ryme Medical Targeted Lung Denervation (TLD) Catheter is safe and effective for people with moderate to severe chronic obstructive pulmonary disease (COPD).
The main questions it aims to answer are:
1. Does the TLD Catheter improve symptoms in people with COPD? 2. Is the TLD Catheter safe ?
Researchers will compare the group receiving the TLD treatment to the group receiving a sham procedure to see if the treatment improves quality of life.
Participants will:
1. Be randomly assigned to receive either the TLD treatment or a sham procedure. 2. Undergo the assigned procedure in a hospital setting. 3. Attend follow-up visits for health checks and breathing tests.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic chronic obstructive pulmonary disease
History of COPD exacerbation(s)
Stable medical therapy
Candidate for bronchoscopy
Disqualifiers
Prior lung intervention with device in place
Using tobacco products, e-cigarettes, vape or other inhaled non-pharmacological substance
Clinically significant serious or unstable medical conditions (e.g., heart disease requiring treatment, uncontrolled diabetes)
Pregnant, nursing, or intent to become pregnant during study duration
Trial design
Crossover
Treatments tested in this trial
Ryme TLD
DeviceRyme TLD Procedure
Sham Control
DeviceSham Control Procedure
Treatment groups
Trial outcomes
Primary outcomes
COPD Assessment Test (CAT)
Change from baseline
Secondary outcomes
St. George Respiratory Questionnaire (SGRQ) Total Score
Change from baseline
Six Minute Walk Test (6MWT)
Change from baseline
COPD exacerbations
Rate of severe post-treatment COPD exacerbations
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: