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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.
ClinicalTrials.gov Identifier:
NCT01328899
First received: April 1, 2011
Last updated: March 11, 2014
Last verified: March 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01328899     History of Changes
Other Study ID Numbers: CLN0011
Study First Received: April 1, 2011
Last Updated: March 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by PneumRx, Inc.:
Emphysema
COPD
RePneu

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

ClinicalTrials.gov processed this record on October 21, 2014