Ryme Medical TLD Pilot Study

Study Overview
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Brief Summary
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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
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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)

Official Title
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Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Targeted Lung Denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm, non-randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Lung Denervation<br>Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System | Device: Targeted Lung Denervation<br>* Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System<br>* Other names: TLD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety | Serious adverse events associated with the Ryme Medical Lung Denervation System | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success |  | Day 0 | 
| Technical Success |  | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Dyspnea, Lung denervation, Bronchoscopic intervention, Lung disease, Lung diseases, obstructive, Respiratory tract diseases