Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Dyspnea, Lung denervation, Bronchoscopic intervention, Lung disease, Lung diseases, obstructive, Respiratory tract diseases
Brief summary
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study
Detailed description
The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)
Interventions
DEVICETargeted Lung Denervation
Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
Sponsors
Ryme Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm, non-randomized
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Symptomatic chronic obstructive pulmonary disease * ≥40 years of age * Smoking history of at least 10 pack years * Candidate for bronchoscopy in the opinion of the Investigator Key
Exclusion criteria
* Recent COPD exacerbation or respiratory infection * Prior lung intervention with device in place * Pulmonary nodule or malignancy requiring treatment * Current chemotherapy or radiation therapy and/or has received treatment within 6 months * Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not prescribed by a physician * 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 |
|---|---|---|
| Device Safety | 30 Days | Serious adverse events associated with the Ryme Medical Lung Denervation System |
Secondary
| Measure | Time frame |
|---|---|
| Device Success | Day 0 |
| Technical Success | Day 0 |
Countries
Australia, Austria, Denmark, Georgia, Netherlands, United Kingdom
Outcome results
None listed