Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.

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Key information

Conditions

Emphysema Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

35 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Donaustauf, Donaustauf, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient > 35 years of age
unilateral or bilateral 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 clinically significant respiratory 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 clinically significant bronchiectasis
Patient has had previous LVR surgery, lung transplant or lobectomy
Patient has been involved in other pulmonary drug studies with 30 days prior to this study
Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Treatment and study plan

Lung Volume Reduction Coil (LVRC)

Device

Implantation of Lung Volume Reduction Coil(s) (LVRC)

Other names: Lung Volume Reduction Surgery (LVRS), Lobectomy

Coils

Device

Lung Volume Reduction Coil(s)

Other names: Lung Volume Reduction Surgery (LVRS), Lobectomy

Primary outcomes

Quality of Life Assessment.

Time frame: Three + Months Follow-Up Visit

Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

PneumRx, Inc.

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Oct 14, 2010
Registry last updated: May 11, 2023

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