The REVIVE Pivotal Study

Sponsor
Ryme Medical, Inc.
Study ID
NCT07361653
Status
Not Yet Recruiting

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Conditions

  • COPD
  • COPD (Chronic Obstructive Pulmonary Disease)
  • COPD Acute Exacerbation
  • COPD Exacerbations
  • COPD Patients
  • Lung Disease Airways
  • Lung Disease, Chronic Obstructive

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ryme TLD — DEVICE
    Ryme TLD Procedure
  • Sham Control — DEVICE
    Sham Control Procedure

Study Details

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.

Key Dates

First listed
Jan 23, 2026
Start date
Jun 30, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Ryme Targeted Lung Denervation (TLD) Procedure
    Ryme TLD Procedure
  • Sham Comparator: Sham Control Procedure
    Sham Control Procedure

Primary Outcome Measure

COPD Assessment Test (CAT) [ Time Frame: 12 months ]

Central Contacts

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