Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Quality of Life (QOL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Quality of Life (QOL)
时间窗: 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.
次要结局
- 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)