Status:
ACTIVE_NOT_RECRUITING
Ryme Medical TLD Pilot Study
Lead Sponsor:
Ryme Medical, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05967091
Start Date
March 6 2024
End Date
May 1 2026
Last Update
August 13 2025
Active Locations (7)
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1
Melbourne Health - The Royal Melbourne Hospital
Melbourne, Australia
2
Macquarie University
Sydney, Australia
3
Karl Landsteiner Institute for Lung Research
Vienna, Austria
4
Rigshospitalet
Copenhagen, Denmark