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Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

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ClinicalTrials.gov Identifier: NCT01220908
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Study Start Date : January 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: permanent Coil(s) implant, QOL measure
Coil implantation as treatment. Treatment is permanent implant.
Device: Lung Volume Reduction Coil (LVRC)
Implantation of Lung Volume Reduction Coil(s) (LVRC)
Other Names:
  • Lung Volume Reduction Surgery (LVRS)
  • Lobectomy
Device: Coils
Lung Volume Reduction Coil(s)
Other Names:
  • Lung Volume Reduction Surgery (LVRS)
  • Lobectomy



Primary Outcome Measures :
  1. 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)



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

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

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): NCT01220908


Locations
Germany
Klinikum Donaustauf
Donaustauf, Germany
Asklepios
Gauting, Germany
Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
Heidelberg, Germany
Lungenklinik
Hemer, Germany
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 3150-3610536
Sponsors and Collaborators
PneumRx, Inc.
Investigators
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Center Groningen
Principal Investigator: Prof. Felix JF Herth, MD, PhD Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01220908     History of Changes
Other Study ID Numbers: CLN0006
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: December 2010

Keywords provided by PneumRx, Inc.:
LVRS (Lung Volume Reduction Surgery)
LVRC (Lung Volume Reduction Coil)
Emphysema
coil
RePneu

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