Ryme Medical TLD Pilot Study

NCT ID: NCT05967091

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2026-05-31

Brief Summary

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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

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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)

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm, non-randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Targeted Lung Denervation

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

Group Type EXPERIMENTAL

Targeted Lung Denervation

Intervention Type DEVICE

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

Interventions

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Targeted Lung Denervation

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

Intervention Type DEVICE

Other Intervention Names

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TLD

Eligibility Criteria

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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

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ryme Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Melbourne Health - The Royal Melbourne Hospital

Melbourne, , Australia

Site Status

Macquarie University

Sydney, , Australia

Site Status

Karl Landsteiner Institute for Lung Research

Vienna, , Austria

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Healthycore

Tbilisi, , Georgia

Site Status

University of Groningen Medical Center

Groningen, , Netherlands

Site Status

Royal Brompton

London, , United Kingdom

Site Status

Countries

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Australia Austria Denmark Georgia Netherlands United Kingdom

Other Identifiers

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2023-01

Identifier Type: -

Identifier Source: org_study_id

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