The Spiration Valve System for the Treatment of Severe Emphysema

Study Overview
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Brief Summary
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This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group. The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Official Title
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The Spiration Valve System for the Treatment of Severe Emphysema

Conditions
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Empyhsema, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Spiration Valve System
* Other: Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has severe emphysema and high heterogeneity by visual assessment defined as: a target lobe with ≥ 40% emphysema involvement and ≥ 15% difference with the ipsilateral lobe. The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be ≥90% complete after viewing the HRCT in 3 dimensions. Patient has received optimal medical management and it has been stable for 6 weeks prior to baseline testing. If pulmonary rehabilitation has been recent, it will be completed at least 3 months prior to baseline testing. Patient must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m. Patient has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study. Severe dyspnea defined as a mMRC ≥ 2. Patient's obstructive disease is severe as defined by: FEV1 ≤ 45% of predicted Patient's hyperinflation is defined by: TLC ≥ 100% of predicted RV ≥ 150% of predicted Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period. Investigator has confirmed that medical management is within standard of care and patient has been stable and without a COPD exacerbation for 6 weeks or more. Exclusion Criteria: Patient has severe gas exchange abnormalities as defined by: PCO2 > 50 mm Hg (6.6 kPa), or PaO2 < 45 mm Hg (6.0 kPa) on room air Patient has a BMI < 15 kg/m2 or > 35 kg/m2 Patient is unable to provide informed consent. Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures. Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise. Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year or has had a COPD exacerbation in the 3 months prior to baseline testing. Patient has bronchitis with sputum production > 60 ml per day. Patient has an active asthma component to their disease or requires more than 15 mg of prednisone daily (20 mg prednisolone). Patient has giant bulla (> 1/3 volume in either lung). Patient has severe pulmonary hypertension based upon clinical evaluation. A patient with a malignant condition and/or a life threatening disease (other than COPD) that would likely affect the completion of the study Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints. This would include neurological or musculoskeletal conditions that may interfere with testing. Patient has had prior lung volume reduction surgery or major lung procedures (lobectomy or greater). Patient has a lung nodule anticipated to require evaluation or intervention during the 3 month study period. Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures. Patient has a diffuse emphysema pattern, diffuse pulmonary fibrosis, or pulmonary tuberculosis (active, extensive, or with adhesive pleural incrassation). Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure. Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study. Female patient of childbearing potential has a positive result from a pregnancy test required during the 7 days prior to the procedure.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Treatment with Spiration Valve System<br>Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. | Device: Spiration Valve System<br> <br> Other: Medical Management<br> <br> |
| Active Comparator: Medical Management<br>The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure. | Other: Medical Management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1) |  | Baseline and 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device-related serious adverse events |  | Baseline and 3 Months | 
| Difference between responder rates in the treatment and control groups, with a responder defined as ≥ 15% improvement in FEV1 |  | Baseline and 3 Months | 
| Target lobe volume reduction as measured by QCT |  | Baseline and 3 Months | 
| Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) |  | Baseline and 3 Months | 
| Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC) |  | Baseline and 3 Months | 
| Exercise capacity as measured by Six Minute Walk Test (6MWT) |  | Baseline and 3 Months | 
| Hyperinflation as measured by Residual Volume (RV) |  | Baseline and 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, BLVR, TLVR, Emphysema, Pulmonary Emphysema, Pathologic Process, Lung Diseases, Respiratory Tract Disease, China, Spiration Valve System (SVS)