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 24, 2013

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 1, 2011
Last Updated Date	March 24, 2013
Start Date ^ICMJE	December 2009
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01328899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
Official Title ^ICMJE	Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Emphysema
Intervention ^ICMJE	Device: Lung Volume Reduction Coil (LVRC) (PneumRx's) Lung Volume Reduction Coil Other Name: Lung Volume Reduction Device (LVRD)
Study Arm (s)	Experimental: Lung Volume Reduction Coil (LVRC) Lung Volume Reduction Coil (LVRC) Intervention: Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	67
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	35 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France, Germany, Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01328899
Other Study ID Numbers ^ICMJE	CLN0011
Has Data Monitoring Committee	No
Responsible Party	PneumRx, Inc.
Study Sponsor ^ICMJE	PneumRx, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	PneumRx, Inc.
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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