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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Physiologic Parameters to Study the Mechanism of Action of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in Subjects With Homogeneous Emphysema

Conditions
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Emphysema

Intervention / Treatment
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* Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LVRC Treatment<br> | Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)<br>* Lung Volume Reduction Coil (LVRC)<br>* Other names: Lobectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test (6MWT) | The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The safety objective of this study is to identify the adverse effects attributed to device. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVRS (Lung Volume Reduction Surgery), LVRC (Lung Volume Reduction Coil), Emphysema, coil, RePneu