Post Market Observational, Prospective, Multi-center Study

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01806636

Enrollment

1275

Registered

2013-03-07

Start date

2013-05-31

Completion date

2019-07-31

Last updated

2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema

Keywords

Coil, RePneu, PneumRx, LVRC

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.

Interventions

DEVICEPneumRx Coil System

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion and

Exclusion criteria

in the Registry are based on CE Mark approved indication and approved Instructions for Use. Patients enrolled and treated in the Registry study should meet the requirements of the PneumRx Endobronchial Coil System Instructions for Use.

Design outcomes

Primary

Measure	Time frame
Changes in Quality of Life (QOL) measures	6 months and yearly up to three years post treatment 1

Secondary

Measure	Time frame
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

Countries

Austria, Denmark, Germany, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026