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

NCT02470052 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-08-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Olympus Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-04-30
Completion
2018-08-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470052 on ClinicalTrials.gov