Active (not recruiting)
Not applicable
NCT05967091
Ryme Medical TLD Pilot Study
No applicable phase (e.g. observational)
Conditions:
Chronic Obstructive Pulmonary Disease
Sponsor: Ryme Medical, Inc.
trial.available_in:
БГ
Overview
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study
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)
Who can participate
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