Ryme Medical TLD Pilot Study
Not Applicable
Not yet recruiting
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Targeted Lung Denervation
- Registration Number
- NCT05967091
- Lead Sponsor
- Ryme Medical, Inc.
- 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)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Targeted Lung Denervation Targeted Lung Denervation Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System
- Primary Outcome Measures
Name Time Method Device Safety 30 Days Serious adverse events associated with the Ryme Medical Lung Denervation System
- Secondary Outcome Measures
Name Time Method Technical Success Day 0 Device Success Day 0