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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
Locations 5
Australia (1)
Melbourne Health - The Royal Melbourne Hospital
Melbourne
Denmark (1)
Rigshospitalet
Copenhagen
Georgia (1)
Healthycore
Tbilisi
Netherlands (1)
University of Groningen Medical Center
Groningen
United Kingdom (1)
Royal Brompton
London
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Healthy volunteers
No
Start date
06.03.2024
Completion date
01.05.2026
Registry ID
NCT05967091
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.