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The REVIVE Pivotal Study
Sponsor: Ryme Medical, Inc.
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. 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.
Official 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
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-06
Completion Date
2029-12
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Ryme TLD
Ryme TLD Procedure
Sham Control
Sham Control Procedure