Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07361653

The REVIVE Pivotal Study

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. Does the TLD Catheter improve symptoms in people with COPD? 2. Is the TLD Catheter safe ?

Researchers will compare the group receiving the TLD treatment to the group receiving a sham procedure to see if the treatment improves quality of life.

Participants will:

1. Be randomly assigned to receive either the TLD treatment or a sham procedure. 2. Undergo the assigned procedure in a hospital setting. 3. Attend follow-up visits for health checks and breathing tests.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) COPD COPD Acute Exacerbation COPD Exacerbations COPD Patients Chronic Disease Disease Attributes Lung Disease Airways Lung Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is a prospective, global, multicenter, randomized, double blind, sham controlled study to evaluate the safety and effectiveness of the Ryme Medical Targeted Lung Denervation (TLD) Catheter compared to sham in patients with moderate and severe symptomatic chronic obstructive pulmonary disease (COPD)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ryme TLD

Device

Ryme TLD Procedure

sham control

Device

Sham Control Procedure

Primary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: 12 months

    Change from baseline

Secondary outcomes

  1. St. George Respiratory Questionnaire (SGRQ) Total Score

    Time frame: 12 months

    Change from baseline

  2. Six Minute Walk Test (6MWT)

    Time frame: 12 months

    Change from baseline

  3. COPD exacerbations

    Time frame: 12 months

    Rate of severe post-treatment COPD exacerbations

Study contacts

Contact information is provided by the study sponsor or research team.

Ryme Medical

CONTACT

[email protected]

+1 (888) 862-1143

Sponsors and collaborators

Lead sponsor

Ryme Medical, Inc.

Industry

Registry information

Official study title

A Prospective, Global, Multicenter, Randomized, Double Blind, Sham Controlled Study to EValuate the Safety and effectIVEness of the Ryme Medical Targeted Lung Denervation (TLD) Catheter in Patients With Moderate and Severe Symptomatic Chronic Obstructive Pulmonary Disease (COPD) - The REVIVE Pivotal Study

Acronym: REVIVE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 23, 2026
Registry last updated
May 5, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.