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Active, Not Recruiting

NCT Number: NCT05967091

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Melbourne Health - The Royal Melbourne Hospital, Melbourne, Australia

Loading trial locations.

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Lung Denervation

Device

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

Other names: TLD

Primary outcomes

  1. Device Safety

    Time frame: 30 Days

    Serious adverse events associated with the Ryme Medical Lung Denervation System

Secondary outcomes

  1. Device Success

    Time frame: Day 0

  2. Technical Success

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Ryme Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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