Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

Study Overview
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Brief Summary
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The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

Official Title
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Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)

Conditions
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Emphysema

Intervention / Treatment
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* Device: Lung Volume Reduction Coil (LVRC) (PneumRx)
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient greater than or equal to 35 years of age High resolution CT scan indicates unilateral or bilateral emphysema High resolution CT scan indicates homogeneous or heterogeneous emphysema Patient has post-bronchodilator FEV1 less than or equal to 45% predicted Total Lung Capacity greater than 100% predicted Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4 Patient has stopped smoking for a minimum of 8 weeks prior to entering the study Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form Exclusion Criteria: Patient has a change in FEV1 greater than 20% post-bronchodilator Patients DLCO less than 20% predicted Patient has a history of recurrent clinically significant respiratory infection Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Patient is pregnant or lactating Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia Patient has clinically significant bronchiectasis Patient has giant bullae greater than 1/3 lung volume Patient has had previous LVR surgery, lung transplant or lobectomy Patient has been involved in other pulmonary drug studies with 30 days prior to this study Patient is taking greater than 20 mg prednisone (or similar steroid) daily Patient is on Plavix or has not been weaned off prior to procedure Patient has other disease 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung Volume Reduction Coil (LVRC)<br>Lung Volume Reduction Coil (LVRC) | Device: Lung Volume Reduction Coil (LVRC) (PneumRx)<br>* Lung Volume Reduction Coil (LVRC)<br>* Other names: LVRD;|
| Placebo Comparator: Control<br>Standard of Care | Device: Control<br>* Standard of Care<br>* Other names: LVRC Control treatment is Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St. George's Respiratory Questionnaire (SGRQ) | The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit. | three month Follow-Up Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, RePneu