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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:
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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ryme Targeted Lung Denervation (TLD) Procedure | Experimental | Ryme TLD Procedure |
|
| Sham Control Procedure | Sham Comparator | Sham Control Procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ryme TLD | Device | Ryme TLD Procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| COPD Assessment Test (CAT) | Change from baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| St. George Respiratory Questionnaire (SGRQ) Total Score | Change from baseline | 12 months |
| Six Minute Walk Test (6MWT) | Change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryme Medical | Contact | +1 (888) 862-1143 | ryme_clinical@rymemedical.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Sham Control |
| Device |
Sham Control Procedure |
|
| 12 months |
| COPD exacerbations | Rate of severe post-treatment COPD exacerbations | 12 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |