COPD (Chronic Obstructive Pulmonary Disease)REVIVENCT07361653
The REVIVE Pivotal Study
A study testing Ryme TLD in people with COPD (Chronic Obstructive Pulmonary Disease) and COPD Exacerbations, run by Ryme Medical, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), COPD Exacerbations, COPD Patients
- What is being tested?
- Ryme TLD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic chronic obstructive pulmonary disease
- History of COPD exacerbation(s)
- Stable medical therapy
- Candidate for bronchoscopy
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- Does the TLD Catheter improve symptoms in people with COPD?
- 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:
- Be randomly assigned to receive either the TLD treatment or a sham procedure.
- Undergo the assigned procedure in a hospital setting.
- Attend follow-up visits for health checks and breathing tests.
Read the 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)
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), COPD Exacerbations, COPD Patients, COPD Acute Exacerbation, COPD, Lung Disease Airways
- Being tested
- Ryme TLD, Sham Control
- Keywords
- COPD, Targeted Lung Denervation, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ryme TLDDevice
Ryme TLD Procedure
Sham ControlDevice
Sham Control Procedure
| Study group | Role | What they receive |
|---|---|---|
| Ryme Targeted Lung Denervation (TLD) Procedure | Experimental | Ryme TLD Procedure Receives: Device: Ryme TLD |
| Sham Control Procedure | Sham comparator | Sham Control Procedure Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test (CAT)
Change from baseline
Measured: 12 months
Secondary outcomes (3)
St. George Respiratory Questionnaire (SGRQ) Total Score
Change from baseline
Measured: 12 months
Six Minute Walk Test (6MWT)
Change from baseline
Measured: 12 months
COPD exacerbations
Rate of severe post-treatment COPD exacerbations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryme Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361653
- Sponsor's protocol ID
- 2025-01
- Acronym
- REVIVE
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07361653
- Acronym / sponsor ID
- REVIVE / 2025-01
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), COPD Exacerbations, COPD Patients, COPD Acute Exacerbation, COPD, Lung Disease Airways
- Keywords
- COPD, Targeted Lung Denervation, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ryme Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the TLD Catheter improve symptoms in people with COPD?
- 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:
- Be randomly assigned to receive either the TLD treatment or a sham procedure.
- Undergo the assigned procedure in a hospital setting.
- Attend follow-up visits for health checks and breathing tests.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ryme Targeted Lung Denervation (TLD) Procedure | Experimental | Device: Ryme TLDRyme TLD Procedure |
| Sham Control Procedure | Sham comparator | Device: Sham ControlSham Control Procedure |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic chronic obstructive pulmonary disease
- History of COPD exacerbation(s)
- Stable medical therapy
- Candidate for bronchoscopy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ryme TLDRyme TLD Procedure | Device | Ryme Targeted Lung Denervation (TLD) Procedure |
| Sham ControlSham Control Procedure | Device | Sham Control Procedure |
Primary outcome
COPD Assessment Test (CAT)
Time frame: 12 months
Change from baseline
3 secondary outcomes
St. George Respiratory Questionnaire (SGRQ) Total Score
Time frame: 12 months
Six Minute Walk Test (6MWT)
Time frame: 12 months
COPD exacerbations
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ryme TLD in people with COPD (Chronic Obstructive Pulmonary Disease) and COPD Exacerbations, run by Ryme Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryme Medical (+1 (888) 862-1143, ryme_clinical@rymemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment Test (CAT) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.