A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration® Valve System for the Single Lobe Treatment of Severe Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 67
- 主要终点
- The primary effectiveness endpoint will be the difference between the treatment and control groups in the mean change in forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the safety and long-term effectiveness of the Spiration Valve System in patients with emphysema.
Patients appropriate for the EMPROVE study are those who are currently on medical treatment but still symptomatic.
EMPROVE also accepts α-1 antitrypsin deficiency patients.
详细描述
The Spiration Valve is a small, one-way valve that is used to block air from entering diseased portions of the lung. This helps to reduce the volume in diseased lung due to hyperinflation. Volume reduction of diseased lung has been shown to improve lung function and other quality of life measures for people living with emphysema.
The Spiration Valve is placed in the diseased section of the lungs using a tool called a bronchoscope. A bronchoscope is a small tube that has a camera on the end. The bronchoscope enters the lungs through the mouth. The Spiration Valve is delivered and placed in the targeted airways via another thin tube called a catheter that travels through the bronchoscope.
- Once in place, the Spiration Valve expands and contracts with breathing, creating a complete seal around the airway
- The seal blocks air from entering the target lobe while at the same time allowing trapped air and fluids to escape.
- This causes the diseased (hyper-inflated) lung to reduce in volume or collapse
- Studies have shown volume reduction may allow healthier lung to function better
- More information and a description of the Spiration Valve System can be found on the EMPROVE clinical trial website, www.EmphysemaTrial.com
Safety and outcomes of the Spiration Valve System in emphysema have been published in several peer-reviewed journals. The articles listed below represent a summary of existing literature regarding the use of the Spiration Valve System for the treatment of emphysema. The selected articles are being provided to help understand the body of data describing the use of the Spiration Valve System.
- Unilateral Versus Bilateral Endoscopic Lung Volume Reduction: A Comparative Case Study, NCT00995852
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has severe and heterogeneous emphysema with severe dyspnea
- •Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD
- •Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m
- •Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study
- •Pulmonary Function Testing Results (PFT's) demonstrate:
- •FEV1 ≤ 45% of predicted
- •RV ≥ 150% of predicted
- •TLC ≥ 100% of predicted
排除标准
- •Patient has a BMI < 15 kg/m2
- •Arterial Blood Gas Level (ABG) indicates:
- •PCO2 > 55 mm Hg
- •PO2 < 45 mm Hg on room air
- •Subject has a diffuse emphysema pattern
- •Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day
- •Subject has an active asthma (>15 mg of prednisone daily)
- •Giant bulla (> 1/3 volume of lung)
- •Pulmonary hypertension
- •Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infections
结局指标
主要结局
The primary effectiveness endpoint will be the difference between the treatment and control groups in the mean change in forced expiratory volume in 1 second (FEV1)
时间窗: Baseline and 6 Months
次要结局
- Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)(Baseline and 6 Months)
- Exercise capacity as measured by Six Minute Walk Test (6MWT)(Baseline and 6 Months)
- Health Status as measured by St. George's Respiratory Questionnaire (SGRQ)(Baseline and 6 Months)
- Target lobe volume reduction as measured by QCT(Baseline and 6 Months)
- Hyperinflation as measured by the ratio of Residual Volume to Total Lung Capacity (RV/TLC)(Baseline and 6 Months)
- FEV1 Responders, defined as those achieving at least 15% improvement from baseline(Baseline and 6 Months)