Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System

Boston Scientific Corporation73 sites in 3 countries1,275 target enrollmentMay 2013

ConditionsEmphysema

Overview

Phase: N/A
Intervention: Not specified
Conditions: Emphysema
Sponsor: Boston Scientific Corporation
Enrollment: 1275
Locations: 73
Primary Endpoint: Changes in Quality of Life (QOL) measures
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This registry is a post market observational, prospective, multi-center registry.

It is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

July 2019

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Changes in Quality of Life (QOL) measures

Time Frame: 6 months and yearly up to three years post treatment 1

Secondary Outcomes

Changes in Pulmonary Function and Exercise Capacity test results(6 months and yearly up to three years post treatment 1)
Safety including any device malfunction or failure(s)(6 months and yearly up to three years post treatment 1)