NCT02470052

A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the OL-BF-001 for Severe Emphysema

A Prospective, Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the OL-BF-001 for Severe Emphysema

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Olympus Corporation · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter,single-arm,open-label study designed to evaluate improvement of lung function and safety after treatment with OL-BF-001 for severe emphysema. OL-BF-001 consists of a bronchial valve, deployment catheter, loader and airway sizing kit. A bronchial valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Conditions

• Emphysema

Interventions

Type	Name	Description
DEVICE	OL-BF-001	Subjects assigned to this study will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. The subjects will also receive medical management.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-04-01
• Completion: 2018-08-01
• First posted: 2015-06-12
• Last updated: 2019-08-28

Locations

10 sites across 1 country: Japan