Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)

This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.

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Key information

Conditions

Emphysema Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CHU de Nice - Hospital Pasteur, Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Greater than or equal to 35 years of age
bilateral heterogenous emphysema
Patient has stopped smoking for a minimum of 8 weeks
Read, understood and signed the Informed consent form

Exclusion criteria

Patient has a history of recurrent significant respirator infection
Patient has an inability to walk > 140 meters
Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
Patient is pregnant or lactating
Patient has clinical significant bronchiectasis
Patient has had previous LVR surgery, lung transplant or lobectomy
Patient has been involved in other pulmonary drug studies within 30 days prior to this study

Treatment and study plan

Lung Volume Reduction Coil (LVRC) (PneumRx's)

Device

Lung Volume Reduction Coil

Other names: Lung Volume Reduction Device (LVRD)

Primary outcomes

St. George's Respiratory Questionnaire

Time frame: 6 months

Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

PneumRx, Inc.

Registry information

Official study title

Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Apr 5, 2011
Registry last updated: Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed