The REVIVE Pivotal Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorRyme Medical, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptomatic chronic obstructive pulmonary disease

History of COPD exacerbation(s)

Stable medical therapy

Candidate for bronchoscopy

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Ryme TLD

    Device

    Ryme TLD Procedure

  • Sham Control

    Device

    Sham Control Procedure

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Ryme Targeted Lung Denervation (TLD) ProcedureExperimental treatment 1 intervention
Group B: Sham Control ProcedureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

COPD Assessment Test (CAT)

Change from baseline

Time frame
12 months

Secondary outcomes

1

St. George Respiratory Questionnaire (SGRQ) Total Score

Change from baseline

Time frame
12 months
2

Six Minute Walk Test (6MWT)

Change from baseline

Time frame
12 months
3

COPD exacerbations

Rate of severe post-treatment COPD exacerbations

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: