Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema

Study Overview
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Brief Summary
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This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

Detailed Description
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This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups

Official Title
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A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema

Conditions
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Emphysema

Intervention / Treatment
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* Device: Endobronchial Coils


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Read, understood and signed the Informed Consent form Meets indications for use per the IFU Bilateral heterogeneous and/or homogeneous emphysema Post bronchodilator 15% predicted ≤ Forced Expiratory Volume in 1 second (FEV1) ≤ 45% predicted Post bronchodilator Residual Volume (RV) ≥ 200% predicted Post bronchodilator Total Lung Capacity (TLC) >100% pred. Post bronchodilator RV/TLC > 55% Dyspnea related to hyperinflation scored ≥ 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management Receiving optimal drug therapy and medical management according to clinical practice. Performing regular physical activity, at least 2 times per week Stopped smoking as confirmed by carboxyhemoglobin (CoHB) 100m ≤ 6 minute walk distance (6MWD) ≤ 450m Deemed eligible per Eligibility Review Committee (ERC) if treated in France, subject must be entitled to French social security. Exclusion Criteria: Known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures are contraindicated Evidence of active infection in the lungs Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals Clinical significant pulmonary fibrosis Clinically significant, generalized bronchiectasis Clinically significant bleeding disorders Patient taking immunosuppressive drugs other than steroids (e.g., for the treatment of cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ rejection). Primary diagnosis of asthma Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations . Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT) Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung. Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease Severe bullous disease (defined by bulla > 8cm or 1/3 of lung volume, or single bullous defect >8 cm) or predominant paraseptal emphysema [defined by numerous large (>1cm) paraseptal defects in the target lobe comprising of >5% of total lung volume]. Lung pathology of nodule not proven stable or benign Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant Use of more than 20 mg/day prednisolone or equivalent dosage of a different corticosteroid Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction) Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg) Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung. Diagnosed with alpha-1 antitrypsin deficiency Diffusion Capacity of the lungs for Carbon Monoxide (DLCO) < 20 % Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months. Body Mass Index (BMI) > 30 Participation in any other clinical Study. Subject is pregnant or lactating, or plan to become pregnant within the study timeframe. If treated in France, Subject is a personnel vulnerable as defined by French Regulation

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: Endobronchial Coils<br>Treatment with PneumRx Endobronchial Coil System | Device: Endobronchial Coils<br>* Endobronchial Coil implants<br>|
| No Intervention: Control<br>Medically-managed control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in FEV1 at 6 Months | Percent change in FEV1 | 6 months | 
| Absolute Change in SGRQ Score at 6 Months | Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe heterogeneous emphysema, severe homogeneous emphysema