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.
This study is a prospective, global, multicenter, randomized, double blind, sham controlled study to evaluate the safety and effectiveness of the Ryme Medical Targeted Lung Denervation (TLD) Catheter compared to sham in patients with moderate and severe symptomatic chronic obstructive pulmonary disease (COPD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Ryme TLD Procedure
Sham Control Procedure
COPD Assessment Test (CAT)
Change from baseline
Time frame: 12 months
St. George Respiratory Questionnaire (SGRQ) Total Score
Change from baseline
Time frame: 12 months
Six Minute Walk Test (6MWT)
Change from baseline
Time frame: 12 months
COPD exacerbations
Rate of severe post-treatment COPD exacerbations
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.