Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema

NCT00475007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2018-04-17

No results posted yet for this study

Summary

This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.

Conditions

Interventions

DEVICE

IBV® Valve System

The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.

Sponsors & Collaborators

  • Olympus Corporation of the Americas

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-02-28
Completion
2017-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT00475007 on ClinicalTrials.gov