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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

April 1, 2011
March 11, 2014
December 2009
January 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01328899 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Emphysema
Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)
Lung Volume Reduction Coil
Other Name: Lung Volume Reduction Device (LVRD)
Experimental: Lung Volume Reduction Coil (LVRC)
Lung Volume Reduction Coil (LVRC)
Intervention: Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Netherlands
 
NCT01328899
CLN0011
No
PneumRx, Inc.
PneumRx, Inc.
Not Provided
Not Provided
PneumRx, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP