COPD, COPD Acute Exacerbation, COPD (Chronic Obstructive Pulmonary Disease), COPD Exacerbations, COPD Patients, Lung Disease Airways, Lung Disease, Chronic Obstructive
Conditions
Keywords
COPD, Targeted Lung Denervation, Chronic Obstructive Pulmonary Disease
Brief summary
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.
Detailed description
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)
Interventions
DEVICERyme TLD
Ryme TLD Procedure
DEVICESham Control
Sham Control Procedure
Sponsors
Ryme Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic chronic obstructive pulmonary disease * History of COPD exacerbation(s) * Stable medical therapy * Candidate for bronchoscopy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD Assessment Test (CAT) | 12 months | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| St. George Respiratory Questionnaire (SGRQ) Total Score | 12 months | Change from baseline |
| Six Minute Walk Test (6MWT) | 12 months | Change from baseline |
| COPD exacerbations | 12 months | Rate of severe post-treatment COPD exacerbations |
Contacts
CONTACTRyme Medical
Outcome results
None listed