Ryme Medical TLD Pilot Study

NCT05967091 | Active Not Recruiting DMC

• 1 other identifier: 2023-01
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 5

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Dyspnea; Lung denervation; Bronchoscopic intervention; Lung disease; Lung diseases, obstructive; Respiratory tract diseases

Outcome Measures

Primary Outcomes (1)

• Device Safety

  Serious adverse events associated with the Ryme Medical Lung Denervation System

  30 Days

Secondary Outcomes (2)

• Device Success

  Day 0

• Technical Success

  Day 0

Study Arms (1)

Targeted Lung Denervation

EXPERIMENTAL

Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System

Device: Targeted Lung Denervation

Interventions

Targeted Lung Denervation DEVICE

Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System

Also known as: TLD

Targeted Lung Denervation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ryme Medical, Inc.: lead

Study Sites (7)

Melbourne Health - The Royal Melbourne Hospital

Melbourne, Australia

Location

Macquarie University

Sydney, Australia

Location

Karl Landsteiner Institute for Lung Research

Vienna, Austria

Location

Rigshospitalet

Copenhagen, Denmark

Location

Healthycore

Tbilisi, Georgia

Location

University of Groningen Medical Center

Groningen, Netherlands

Location

Royal Brompton

London, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Lung Diseases; Lung Diseases, Obstructive; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, non-randomized

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 1, 2023
• Study Start: March 6, 2024
• Primary Completion: May 22, 2025
• Study Completion: May 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); AU (1); GB (1); GE (1); NL (1)