Ryme Medical TLD Pilot Study

August 7, 2025 updated by: Ryme Medical, Inc.

Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study

Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Melbourne Health - The Royal Melbourne Hospital
      • Sydney, Australia
        • Macquarie University
  • Austria
      • Vienna, Austria
        • Karl Landsteiner Institute for Lung Research
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • Georgia
      • Tbilisi, Georgia
        • Healthycore
  • Netherlands
      • Groningen, Netherlands
        • University of Groningen Medical Center
  • United Kingdom
      • London, United Kingdom
        • Royal Brompton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Targeted Lung Denervation
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System
Device: Targeted Lung Denervation
Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
Other Names:
  • TLD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Safety
Time Frame: 30 Days
Serious adverse events associated with the Ryme Medical Lung Denervation System
30 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Device Success
Time Frame: Day 0
Day 0
Technical Success
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryme Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Actual)

May 22, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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