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

Completed · Not applicable

Conditions studied: Emphysema

In brief

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.

Key facts

Study ID

NCT01812447

Run by

Olympus Corporation of the Americas

People needed

172

Starts

2013-06-01

Expected to finish

2022-08-01

Last updated by the study team

2024-05-31

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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