Status:
COMPLETED
Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function
Lead Sponsor:
Olympus Corporation of the Americas
Conditions:
Emphysema
Eligibility:
All Genders
40+ years
Phase:
NA
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 appr...
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 redu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT01812447
Start Date
June 1 2013
End Date
August 1 2022
Last Update
May 31 2024
Active Locations (34)
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1
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
2
Kaiser Permanente Riverside Medical Center
Riverside, California, United States, 92505
3
University of California San Diego
San Diego, California, United States, 92103
4
California Pacific Medical Center
San Francisco, California, United States, 94115