COPDDISCOVER TLDNCT03213080
Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population
An observational study of COPD, run by Nuvaira, Inc..
Trial summary
The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Targeted Lung Denervation (TLD)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of advanced COPD [20% ≤ FEV1 ≤ 45% and FEV1/FVC < 70% (post-bronchodilator)] who are no longer smoking (quit at least 2 months prior to registry consent) and are able to undergo general anesthesia. All subjects will undergo a CT scan to determine whether bronchial anatomy is appropriate for TLD procedure.
Who may be able to join
- Diagnosis of COPD with 20% ≤ FEV1 ≤ 45% and FEV1/FVC < 70% (post-bronchodilator)
- History of long-term smoking, but non-smoking for a minimum of 2 months prior to study consent
- Patient is a candidate for bronchoscopy
- Patient agrees to all follow-up and provides written informed consent.
Who cannot join
- Presence of lung or chest implants (eg. metal stent, valves, coils)
- Pregnancy
- Pre-existing pulmonary hypertension
- Patient has a pacemaker, internal defibrillator, or other implantable electronic device
- Inappropriate bronchial anatomy for procedure (per CT scan)
- Previous abdominal surgical procedures on stomach, esophagus or pancreas
Show all 10Show fewer
- Previous treatment with TLD Therapy (in same areas)
- Known allergy to bronchoscopy or general anesthesia medications
- Inability to tolerate single lung ventilation for at least 2 min, 30 sec
- Patient has a GCSI score of ≥ 18 at time of screening visit
About this study
The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe.
Read the detailed description
The purpose of this study is to evaluate the overall COPD patient experience with the Nuvaira™ Lung Denervation System and allow for the continued collection of safety and effectiveness data on the CE-marked product. The study is a multicenter, prospective, single-arm study designed to include patients, on average, who fall within a more severe stage of COPD, defined as 20-45% FEV1 percent predicted. Subjects will remain on respiratory medications per their standard of care and will be followed and tested per standard of care throughout the study.
- Conditions
- COPD
- Being tested
- Targeted Lung Denervation (TLD)
- Keywords
- Targeted Lung Denervation, TLD
- 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.
Targeted Lung Denervation (TLD)Device
Targeted Lung Denervation (TLD) procedure.
| Study group | Role | What they receive |
|---|---|---|
| TLD Procedure | All subjects who are enrolled and meet the eligibility criteria will undergo Targeted Lung Denervation (TLD). TLD is a bronchoscopically-guided, minimally-invasive procedure using the Nuvaira™ Lung Devervation System. The Nuvaira System is intended for the long-term maintenance treatment of airway obstruction associated with COPD. TLD uses radiofrequency (RF) energy to ablate the airway nerve trunks of the vagus nerves that travel parallel to and outside of the main bronchi and into the lungs. Ablation of the nerves opens the airways and makes breathing easier. Receives: Device: Targeted Lung Denervation (TLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (QOL)
Changes in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) over time will be assessed. Comparisons will be made to baseline score.
Measured: 6 months; 12 months; 24 months post-procedure
Secondary outcomes (4)
Changes in Pulmonary Function
Basic spirometry tests including FEV1, FVC, forced impulse oscillometry, nitrogen wash-out measures will be performed per standard of care over time. Comparisons will be made to baseline measures.
Measured: 6 months, 12 months, 24 months post-procedure
Change in 6-Minute Walk Test
Change in 6MWT over time
Measured: 6 months, 1 year, 2 years
Respiratory-related Adverse Events
Respiratory-related adverse events will be collected throughout the registry. Rates of respiratory-related adverse events will be reported and compared to historical data.
Measured: 24 months
Freedom from Device-related Adverse Events
Device-related adverse events will be collected through 6 months post-procedure. The number of subjects free from a device-related adverse event will be reported.
Measured: Peri-procedure (within 7 days); 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startDec 2017 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvaira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213080
- Sponsor's protocol ID
- D0476
- Acronym
- DISCOVER TLD
- Status last verified
- Feb 2019
- First submitted
- 6 Jul 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population
- ClinicalTrials.gov ID
- NCT03213080
- Acronym / sponsor ID
- DISCOVER TLD / D0476
- Conditions
- COPD
- Keywords
- Targeted Lung Denervation, TLD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nuvaira, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2017 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 11 Jul 2017 (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 DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe.
Detailed description
The purpose of this study is to evaluate the overall COPD patient experience with the Nuvaira™ Lung Denervation System and allow for the continued collection of safety and effectiveness data on the CE-marked product. The study is a multicenter, prospective, single-arm study designed to include patients, on average, who fall within a more severe stage of COPD, defined as 20-45% FEV1 percent predicted. Subjects will remain on respiratory medications per their standard of care and will be followed and tested per standard of care throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TLD Procedure | – | Device: Targeted Lung Denervation (TLD)All subjects who are enrolled and meet the eligibility criteria will undergo Targeted Lung Denervation (TLD). TLD is a bronchoscopically-guided, minimally-invasive procedure using the Nuvaira™ Lung Devervation System. The Nuvaira System is intended for the long-term maintenance treatment of airway obstruction associated with COPD. TLD uses radiofrequency (RF) energy to ablate the airway nerve trunks of the vagus nerves that travel parallel to and outside of the main bronchi and into the lungs. Ablation of the nerves opens the airways and makes breathing easier. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of advanced COPD [20% ≤ FEV1 ≤ 45% and FEV1/FVC < 70% (post-bronchodilator)] who are no longer smoking (quit at least 2 months prior to registry consent) and are able to undergo general anesthesia. All subjects will undergo a CT scan to determine whether bronchial anatomy is appropriate for TLD procedure.
Key inclusion criteria (4 listed)
- Diagnosis of COPD with 20% ≤ FEV1 ≤ 45% and FEV1/FVC < 70% (post-bronchodilator)
- History of long-term smoking, but non-smoking for a minimum of 2 months prior to study consent
- Patient is a candidate for bronchoscopy
- Patient agrees to all follow-up and provides written informed consent.
Key exclusion criteria (10 listed)
- Presence of lung or chest implants (eg. metal stent, valves, coils)
- Pregnancy
- Pre-existing pulmonary hypertension
- Patient has a pacemaker, internal defibrillator, or other implantable electronic device
- Inappropriate bronchial anatomy for procedure (per CT scan)
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 Denervation (TLD)Targeted Lung Denervation (TLD) procedure. | Device | TLD Procedure |
Primary outcome
Change in Quality of Life (QOL)
Time frame: 6 months; 12 months; 24 months post-procedure
Changes in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) over time will be assessed. Comparisons will be made to baseline score.
4 secondary outcomes
Changes in Pulmonary Function
Time frame: 6 months, 12 months, 24 months post-procedure
Change in 6-Minute Walk Test
Time frame: 6 months, 1 year, 2 years
Respiratory-related Adverse Events
Time frame: 24 months
Freedom from Device-related Adverse Events
Time frame: Peri-procedure (within 7 days); 1 month and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Nuvaira Website with description of TLD procedureLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Nuvaira, 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 10 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: withdrawn, as of the sponsor's last update on 18 Feb 2019. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Quality of Life (QOL) (time frame: 6 months; 12 months; 24 months post-procedure). 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 18 Feb 2019.