Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function
- Conditions
- Emphysema
- Interventions
- Device: Spiration Valve SystemOther: Medical Management
- Registration Number
- NCT01812447
- Lead Sponsor
- Olympus Corporation of the Americas
- 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.
1. Unilateral Versus Bilateral Endoscopic Lung Volume Reduction: A Comparative Case Study, NCT00995852
Eberhardt R, Gompelmann D, Schuhmann M, Heussel CP, Herth FJ. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908
2. Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema (IBV®Valve), NCT00475007
Wood DE, Nader DA, Springmeyer SC, Elstad MR, Coxson HO, Chan A, Rai NS, Mularski RA, Cooper CB, Wise RA, Jones PW, Mehta AC, Gonzalez X, Sterman DH; IBV Valve Trial Research Team. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014 Oct;21(4):288-297
3. European Multi-Center Post Market Study of the IBV Valve System, NCT00880724
Ninane V, Geltner C, Bezzi M, Foccoli P, Gottlieb J, Welte T, Seijo L, Zulueta JJ, Munavvar M, Rosell A, Lopez M, Jones PW, Coxson HO, Springmeyer SC, Gonzalez X. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012 Jun;39(6):1319-1325
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spiration Valve System 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. Spiration Valve System Medical Management 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. Spiration Valve System, α-1 Spiration Valve System 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. Spiration Valve System, α-1 Medical Management 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. Medical Management 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.
- Primary Outcome Measures
Name Time Method 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) Baseline and 6 Months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (34)
Kaiser Permanente Riverside Medical Center
🇺🇸Riverside, California, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Beaumont Botsford Hospital (DCRC)
🇺🇸Farmington Hills, Michigan, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Cornell NYPH
🇺🇸New York, New York, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Michael DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Miami VA Healthcare System
🇺🇸Miami, Florida, United States
University of California San Diego
🇺🇸San Diego, California, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Sparks Regional Medical Center
🇺🇸Fort Smith, Arkansas, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Louisiana State University Hospital
🇺🇸Shreveport, Louisiana, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Kaiser Permanente Northwest Medical Center
🇺🇸Clackamas, Oregon, United States
Fletcher Allen Medical Center
🇺🇸Burlington, Vermont, United States
Laval University
🇨🇦Québec, Quebec, Canada
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States