Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- Nuvaira, Inc.
- Primary Endpoint
- Change in Quality of Life (QOL)
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Changes in Pulmonary Function(6 months, 12 months, 24 months post-procedure)
- Change in 6-Minute Walk Test(6 months, 1 year, 2 years)
- Respiratory-related Adverse Events(24 months)
- Freedom from Device-related Adverse Events(Peri-procedure (within 7 days); 1 month and 6 months)