Chronic Obstructive Pulmonary DiseaseNCT05967091
Ryme Medical TLD Pilot Study
A study testing Targeted Lung Denervation in people with Chronic Obstructive Pulmonary Disease, run by Ryme Medical, Inc. at 7 sites in 6 countries.
Trial summary
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Targeted Lung Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 6 Mar 2024to May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic chronic obstructive pulmonary disease
- ≥40 years of age
- Smoking history of at least 10 pack years
- Candidate for bronchoscopy in the opinion of the Investigator
Who cannot join
- Recent COPD exacerbation or respiratory infection
- Prior lung intervention with device in place
- Pulmonary nodule or malignancy requiring treatment
- Current chemotherapy or radiation therapy and/or has received treatment within 6 months
- Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not prescribed by a physician
- 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
7 sites in 6 countries.
7 sites in 6 countries
Australia2 sites
Melbourne Health - The Royal Melbourne Hospital
Melbourne
Macquarie University
Sydney
About this study
Official title: Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study
Read the detailed description
The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Targeted Lung Denervation
- Keywords
- COPD, Dyspnea, Lung denervation, Bronchoscopic intervention, Lung disease, Lung diseases, obstructive, Respiratory tract diseases
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Lung Diseases, Lung Diseases, Obstructive, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Lung DenervationDevice
Also called TLD
Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
| Study group | Role | What they receive |
|---|---|---|
| Targeted Lung Denervation | Experimental | Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System Receives: Device: Targeted Lung Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Safety
Serious adverse events associated with the Ryme Medical Lung Denervation System
Measured: 30 Days
Secondary outcomes (2)
Device Success
Measured: Day 0
Technical Success
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start6 Mar 2024
- Primary completion22 May 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, non-randomized
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT05967091
- Sponsor's protocol ID
- 2023-01
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2023
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study
- ClinicalTrials.gov ID
- NCT05967091
- Acronym / sponsor ID
- 2023-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Dyspnea, Lung denervation, Bronchoscopic intervention, Lung disease, Lung diseases, obstructive, Respiratory tract diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ryme Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Aug 2023 (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.
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study
Detailed description
The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, non-randomized
| Arm | Type | Receives |
|---|---|---|
| Targeted Lung Denervation | Experimental | Device: Targeted Lung DenervationTargeted lung denervation (TLD) with the Ryme Medical Lung Denervation System |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic chronic obstructive pulmonary disease
- ≥40 years of age
- Smoking history of at least 10 pack years
- Candidate for bronchoscopy in the opinion of the Investigator
Key exclusion criteria (7 listed)
- Recent COPD exacerbation or respiratory infection
- Prior lung intervention with device in place
- Pulmonary nodule or malignancy requiring treatment
- Current chemotherapy or radiation therapy and/or has received treatment within 6 months
- Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not prescribed by a physician
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 |
|---|---|---|
| Targeted Lung DenervationAlso: TLDTargeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System | Device | Targeted Lung Denervation |
Primary outcome
Device Safety
Time frame: 30 Days
Serious adverse events associated with the Ryme Medical Lung Denervation System
2 secondary outcomes
Device Success
Time frame: Day 0
Technical Success
Time frame: Day 0
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 13 Aug 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Lung Denervation in people with Chronic Obstructive Pulmonary Disease, run by Ryme Medical, Inc. at 7 sites in 6 countries.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Austria, Denmark, Georgia, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety (time frame: 30 Days). 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 13 Aug 2025.