The REVIVE Pivotal Study

Ryme Medical

Status: Begins enrollment in 3 months

Conditions: COPD (Chronic Obstructive Pulmonary Disease); Lung Disease Airways; COPD Acute Exacerbation; COPD Patients; COPD; COPD Exacerbations; Lung Disease, Chronic Obstructive

Treatments: Device: Ryme TLD; Device: Sham Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT07361653

2025-01

Details and patient eligibility

About

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.

Full 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)

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Ryme Targeted Lung Denervation (TLD) Procedure

Experimental group

Description:

Ryme TLD Procedure

Treatment:

Device: Ryme TLD

Sham Control Procedure

Sham Comparator group

Description:

Sham Control Procedure

Treatment:

Device: Sham Control