The REVIVE Pivotal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ryme TLD, Sham Control.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), COPD Exacerbations, COPD Patients, COPD Acute Exacerbation. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed description
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)
Interventions
- Device Ryme TLD
Ryme TLD Procedure - Device Sham Control
Sham Control Procedure
Primary outcome measures
- COPD Assessment Test (CAT) [Time frame: 12 months]
Secondary outcome measures (3)
- St. George Respiratory Questionnaire (SGRQ) Total Score [Time frame: 12 months]
- Six Minute Walk Test (6MWT) [Time frame: 12 months]
- COPD exacerbations [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07361653 · 2025-01