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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01328899
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : July 21, 2021
PneumRx, Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Emphysema Device: Lung Volume Reduction Coil (LVRC) (PneumRx's) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Study Start Date : December 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: Lung Volume Reduction Coil (LVRC)
Lung Volume Reduction Coil (LVRC)
Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)
Lung Volume Reduction Coil
Other Name: Lung Volume Reduction Device (LVRD)

Primary Outcome Measures :
  1. St. George's Respiratory Questionnaire [ Time Frame: 6 months ]
    Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328899

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CHU de Nice - Hospital Pasteur
Nice, France
Gaetan Deslee
Reims, France
CHRU de Strasbourg-NHC
Strasbourg, France
Campus Charite Mitte
Berlin, Germany
Klinikum Donaustauf
Donaustauf, Germany
Gauting, Germany
Heidelberg, Germany
Hemer, Germany
Krankenhaus von Roten Kreuz
Stuttgart, Germany
UKT University Hospital
Teubingen, Germany
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
Boston Scientific Corporation
PneumRx, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01328899    
Other Study ID Numbers: CLN0011
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Keywords provided by Boston Scientific Corporation:
Additional relevant MeSH terms:
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Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases