Ryme Medical TLD Pilot Study

Not Applicable

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• 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)

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Study Start: 2024-03-06
• Primary Completion: 2025-05-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-13
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_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

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

Trial Locations

Locations (7)

Melbourne Health - The Royal Melbourne Hospital; 🇦🇺 Melbourne, Australia

Macquarie University; 🇦🇺 Sydney, Australia

Karl Landsteiner Institute for Lung Research; 🇦🇹 Vienna, Austria

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Healthycore; 🇬🇪 Tbilisi, Georgia

University of Groningen Medical Center; 🇳🇱 Groningen, Netherlands

Royal Brompton; 🇬🇧 London, United Kingdom