Evaluation of the IBV® Valve for Emphysema to Improve Lung Function (EMPROVE)


Pioneer Founding member
Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
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 or > 35 kg/m2
•Arterial Blood Gas Level (ABG) indicates:
◦PCO2 > 50 mm Hg
◦PO2 < 45 mm Hg on room air

•Subject has a diffuse emphysema pattern or α1-antitrypsin deficiency
•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

Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812447

Click on this link for contact information