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

NCT ID: NCT01812447

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2022-08-31

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

Conditions

Emphysema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Spiration Valve System

Intervention Type: DEVICE

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.

Medical Management

Intervention Type: OTHER

Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.

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.

Group Type: EXPERIMENTAL

Spiration Valve System

Intervention Type: DEVICE

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.

Medical Management

Intervention Type: OTHER

Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.

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.

Group Type: ACTIVE_COMPARATOR

Medical Management

Intervention Type: OTHER

Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.

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.

Intervention Type: DEVICE

Medical Management

Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olympus Corporation of the Americas

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

University of California San Diego

San Diego, California, United States

California Pacific Medical Center

San Francisco, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Miami VA Healthcare System

Miami, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Louisiana State University Hospital

Shreveport, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

Beaumont Botsford Hospital (DCRC)

Farmington Hills, Michigan, United States

Cooper University Hospital

Camden, New Jersey, United States

Cornell NYPH

New York, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Kaiser Permanente Northwest Medical Center

Clackamas, Oregon, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Michael DeBakey VA Medical Center

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Fletcher Allen Medical Center

Burlington, Vermont, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

University of Calgary

Calgary, Alberta, Canada

Laval University

Québec, Quebec, Canada

Countries

United States; Canada

References

Criner GJ, Delage A, Voelker K, Hogarth DK, Majid A, Zgoda M, Lazarus DR, Casal R, Benzaquen SB, Holladay RC, Wellikoff A, Calero K, Rumbak MJ, Branca PR, Abu-Hijleh M, Mallea JM, Kalhan R, Sachdeva A, Kinsey CM, Lamb CR, Reed MF, Abouzgheib WB, Kaplan PV, Marrujo GX, Johnstone DW, Gasparri MG, Meade AA, Hergott CA, Reddy C, Mularski RA, Case AH, Makani SS, Shepherd RW, Chen B, Holt GE, Martel S. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 1;200(11):1354-1362. doi: 10.1164/rccm.201902-0383OC.

Reference Type: RESULT

PMID: 31365298 (View on PubMed)

Hogarth DK, Delage A, Zgoda MA, Nsiah-Dosu S, Himes D, Reed MF. Efficacy and safety of the Spiration Valve System for the treatment of severe emphysema in patients with Alpha-1 antitrypsin deficiency (EMPROVE). Respir Med. 2024 Apr;224:107565. doi: 10.1016/j.rmed.2024.107565. Epub 2024 Feb 14.

Reference Type: RESULT

PMID: 38364975 (View on PubMed)

Criner GJ, Mallea JM, Abu-Hijleh M, Sachdeva A, Kalhan R, Hergott CA, Lazarus DR, Mularski RA, Calero K, Reed MF, Nsiah-Dosu S, Himes D, Kubo H, Kinsey CM, Majid A, Hogarth DK, Kaplan PV, Case AH, Makani SS, Chen TM, Delage A, Zgoda M, Shepherd RW. Sustained Clinical Benefits of Spiration Valve System in Patients with Severe Emphysema: 24-Month Follow-Up of EMPROVE. Ann Am Thorac Soc. 2024 Feb;21(2):251-260. doi: 10.1513/AnnalsATS.202306-520OC.

Reference Type: RESULT

PMID: 37948704 (View on PubMed)

Other Identifiers

CPR-03434

Identifier Type: -

Identifier Source: org_study_id