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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328899
First Posted: April 5, 2011
Last Update Posted: March 12, 2014
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.
Information provided by (Responsible Party):
PneumRx, Inc.
  Purpose
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 Intervention Phase
Emphysema Device: Lung Volume Reduction Coil (LVRC) (PneumRx's) Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by PneumRx, Inc.:

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


Enrollment: 60
Study Start Date: December 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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


Locations
France
CHU de Nice - Hospital Pasteur
Nice, France
Gaetan Deslee
Reims, France
CHRU de Strasbourg-NHC
Strasbourg, France
Germany
Campus Charite Mitte
Berlin, Germany
Klinikum Donaustauf
Donaustauf, Germany
Asklepios
Gauting, Germany
Thoraxklinik
Heidelberg, Germany
Lungenklinik
Hemer, Germany
Krankenhaus von Roten Kreuz
Stuttgart, Germany
UKT University Hospital
Teubingen, Germany
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
PneumRx, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01328899     History of Changes
Other Study ID Numbers: CLN0011
First Submitted: April 1, 2011
First Posted: April 5, 2011
Last Update Posted: March 12, 2014
Last Verified: March 2012

Keywords provided by PneumRx, Inc.:
Emphysema
COPD
RePneu

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases