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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 172
- Locations
- 34
- Primary Endpoint
- 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)
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Spiration Valve System
Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management.
Intervention: Spiration Valve System (Device)
Spiration Valve System
Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management.
Intervention: Medical Management (Other)
Spiration Valve System, α-1
α-1 antitrypsin deficiency subjects will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. There is no randomization for this group.
Intervention: Spiration Valve System (Device)
Spiration Valve System, α-1
α-1 antitrypsin deficiency subjects will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. There is no randomization for this group.
Intervention: Medical Management (Other)
Medical Management
The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure.
Intervention: Medical Management (Other)
Outcomes
Primary Outcomes
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)
Time Frame: Baseline and 6 Months
Secondary Outcomes
- 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)