The REVIVE Pivotal Study (REVIVE)

April 29, 2026 updated by: Ryme Medical, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ryme Targeted Lung Denervation (TLD) Procedure
Ryme TLD Procedure
Device: Ryme TLD
Ryme TLD Procedure
Sham Comparator: Sham Control Procedure
Device: Sham Control
Sham Control Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD Assessment Test (CAT)
Time Frame: 12 months
Change from baseline
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St. George Respiratory Questionnaire (SGRQ) Total Score
Time Frame: 12 months
Change from baseline
12 months
Six Minute Walk Test (6MWT)
Time Frame: 12 months
Change from baseline
12 months
COPD exacerbations
Time Frame: 12 months
Rate of severe post-treatment COPD exacerbations
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryme Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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