The REVIVE Pivotal Study
NCT07361653 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-05-05
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.
Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- COPD Exacerbations
- COPD Patients
- COPD Acute Exacerbation
- COPD
- Lung Disease Airways
- Lung Disease, Chronic Obstructive
Interventions
- DEVICE
-
Ryme TLD
Ryme TLD Procedure
- DEVICE
-
Sham Control
Sham Control Procedure
Sponsors & Collaborators
-
Ryme Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
- FDA Device
- Yes
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