Trials / Not Yet Recruiting
Not Yet RecruitingNCT07361653
The REVIVE Pivotal Study
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Ryme Medical, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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)
Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- COPD Exacerbations
- COPD Patients
- COPD Acute Exacerbation
- COPD
- Lung Disease Airways
- Lung Disease, Chronic Obstructive
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ryme TLD | Ryme TLD Procedure |
| DEVICE | Sham Control | Sham Control Procedure |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-12-01
- Completion
- 2029-12-01
- First posted
- 2026-01-23
- Last updated
- 2026-01-23
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07361653. Inclusion in this directory is not an endorsement.