COPD
Conditions
Keywords
Targeted Lung Denervation, TLD
Brief 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.
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.
Interventions
Targeted Lung Denervation (TLD) procedure.
Sponsors
Nuvaira, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pulmonary Function | 6 months, 12 months, 24 months post-procedure | 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. |
| Change in 6-Minute Walk Test | 6 months, 1 year, 2 years | Change in 6MWT over time |
| Respiratory-related Adverse Events | 24 months | Respiratory-related adverse events will be collected throughout the registry. Rates of respiratory-related adverse events will be reported and compared to historical data. |
| Freedom from Device-related Adverse Events | Peri-procedure (within 7 days); 1 month and 6 months | 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. |
Outcome results
None listed