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Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema

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ClinicalTrials.gov Identifier: NCT01421082
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.

Condition or disease Intervention/treatment Phase
Emphysema Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.) Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Physiologic Parameters to Study the Mechanism of Action of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in Subjects With Homogeneous Emphysema
Study Start Date : February 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LVRC Treatment Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)
Lung Volume Reduction Coil (LVRC)
Other Names:
  • Lung Volume Reduction Surgery (LVRS)
  • Lobectomy


Outcome Measures

Primary Outcome Measures :
  1. 6 minute walk test (6MWT) [ Time Frame: 6 months ]
    The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 months ]
    The safety objective of this study is to identify the adverse effects attributed to device.


Eligibility Criteria

Information from the National Library of Medicine

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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:

Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

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): NCT01421082


Locations
Netherlands
University Medical Center Groningen - UMCG
Groningen, The Netherlands, Netherlands, 9700 RB
Sponsors and Collaborators
PneumRx, Inc.
More Information

Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01421082     History of Changes
Other Study ID Numbers: CLN0012
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: December 2012

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