NCT07361653

Brief Summary

The goal of this study is to test whether a new treatment called the Ryme Medical Targeted Lung Denervation (TLD) Catheter is safe and effective for people with moderate to severe chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are:

  1. 1.Does the TLD Catheter improve symptoms in people with COPD?
  2. 2.Is the TLD Catheter safe ?
  3. 3.Be randomly assigned to receive either the TLD treatment or a sham procedure.
  4. 4.Undergo the assigned procedure in a hospital setting.
  5. 5.Attend follow-up visits for health checks and breathing tests.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Jun 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

January 21, 2026

Last Update Submit

April 29, 2026

Conditions

COPD (Chronic Obstructive Pulmonary Disease)COPD ExacerbationsCOPD PatientsCOPDCOPD Acute ExacerbationLung Disease AirwaysLung Disease, Chronic Obstructive

Keywords

COPDTargeted Lung DenervationChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • COPD Assessment Test (CAT)

    Change from baseline

    12 months

Secondary Outcomes (3)

  • St. George Respiratory Questionnaire (SGRQ) Total Score

    12 months

  • Six Minute Walk Test (6MWT)

    12 months

  • COPD exacerbations

    12 months

Study Arms (2)

Ryme Targeted Lung Denervation (TLD) Procedure

EXPERIMENTAL

Ryme TLD Procedure

Device: Ryme TLD

Sham Control Procedure

SHAM COMPARATOR

Sham Control Procedure

Device: Sham Control

Interventions

Ryme TLDDEVICE

Ryme TLD Procedure

Ryme Targeted Lung Denervation (TLD) Procedure
Sham ControlDEVICE

Sham Control Procedure

Sham Control Procedure

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic chronic obstructive pulmonary disease
  • History of COPD exacerbation(s)
  • Stable medical therapy
  • Candidate for bronchoscopy

You may not qualify if:

  • Prior lung intervention with device in place
  • Using tobacco products, e-cigarettes, vape or other inhaled non-pharmacological substance
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ryme Medical

CONTACT

+1 (888) 862-1143ryme_clinical@rymemedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 23, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share