Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function



Status:Active, not recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:2/16/2018
Start Date:June 2013
End Date:May 2022

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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

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.

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

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
We found this trial at
33
sites
1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Principal Investigator: Amy Case, MD
Phone: 770-745-1404
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Adnan Majid, MD
Phone: 617-632-8386
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael Zgoda, MD
Phone: 704-355-0244
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Kyle Hogarth, MD
Phone: 773-834-8874
University of Chicago One of the world's premier academic and research institutions, the University of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Otis Rickman, DO
Phone: 615-343-8010
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Chak Reddy, MD
Phone: 801-581-5811
University of Utah Research is a major component in the life of the U benefiting...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Mark Rumbak, MD
Phone: 813-844-7647
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Ashutosh Sachdeva, MD
Phone: 410-328-1473
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Principal Investigator: Carla Lamb, MD
Phone: 781-744-3706
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Burlington, Vermont 05405
Principal Investigator: Matt Kinsey, MD
Phone: 802-656-7953
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Calgary, Alberta
Principal Investigator: Christopher Hergott, MD
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Wissam Abouzgheib, MD
Phone: 856-968-7269
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Ravi Kalhan, MD
Phone: 312-695-4828
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Sadia Benzaquen, MD
Phone: 513-558-0027
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Clackamas, Oregon 97015
Principal Investigator: Richard Mularski, MD
Phone: 503-571-6181
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Dallas, Texas 75390
Principal Investigator: Muhanned Abu-Hijleh, MD
Phone: 214-645-9730
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Farmington Hills, Michigan 48336
Principal Investigator: Philip Kaplan, DO
Phone: 248-716-7009
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Fort Smith, Arkansas 72901
Principal Investigator: Arturo Meade, MD
Phone: 479-441-4938
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Michael Reed, MD
Phone: 717-531-6010
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
Principal Investigator: Roberto Casal, MD
Phone: 713-794-7294
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Jacksonville, Florida 32216
Principal Investigator: Jorge Mallea, MD
Phone: 904-953-2255
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Knoxville, Tennessee 37920
Principal Investigator: Paul Branca, MD
Phone: 865-305-9100
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Miami, Florida 33136
Principal Investigator: Gregory Holt, MD
Phone: 305-575-7000
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: David Johnstone, MD
Phone: 414-955-6994
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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New York, New York 10065
Principal Investigator: Eugene Shostak, MD
Phone: 212-746-3328
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Gerard Criner, MD
Phone: 215-707-1559
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Frank Sciurba, MD
Phone: 412-864-3368
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Ray Shepherd, MD
Phone: 804-828-7966
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Riverside, California 92505
Principal Investigator: Greg Marrujo, MD
Phone: 951-353-5801
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San Diego, California 92093
Principal Investigator: Samir Makani, MD
Phone: 619-543-2291
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Benson Chen, MD
Phone: 415-600-1107
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Principal Investigator: Kirk Voelker, MD
Phone: 941-917-3614
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Shreveport, Louisiana 71130
Principal Investigator: Robert Holladay, MD
Phone: 318-675-7298
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